Adalimumab

European Union, central authorisation (16)

Amgevita, Amsparity, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Imraldi, Libmyris, Yuflyma, Cyltezo (withdrawn), Fyzoclad (application withdrawn), Halimatoz (withdrawn), Kromeya (withdrawn), Solymbic (withdrawn) [5]

France (10)

AMGEVITA, AMSPARITY, HUKYNDRA, HULIO, HUMIRA, HYRIMOZ, IDACIO, IMRALDI, LIBMYRIS, YUFLYMA [6]

United Kingdom (5)

Humira, Amgevita HCF, Hyrimoz, Imraldi, Yuflyma [7]

Links lead to the official product page: the EPAR for the European Union, the public medicines database for France, the CIMA summary of product characteristics for Spain, the dm+d for the United Kingdom. An asterisk marks a name taken from the DysNet register only.

• Amgevita · authorised · biosimilar · Amgen Europe B.V. · authorised 21 March 2017
  Indication (EMA text)

  Rheumatoid arthritis Amgevita in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Amgevita reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amgevita in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amgevita is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. Psoriatic arthritis Amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Amgevita reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function. Psoriasis Amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Amgevita is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Amgevita is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Amgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Amgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Amgevita is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Amsparity · authorised · biosimilar · Pfizer Europe MA EEIG · authorised 13 February 2020
  Indication (EMA text)

  Rheumatoid arthritis Amsparity in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amsparity in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amsparity is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis Ankylosing spondylitis (AS) Amsparity is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Amsparity is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Amsparity is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Amsparity is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amsparity is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Amsparity is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Amsparity is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Amsparity is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Amsparity is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Adolescent hidradenitis suppurativa Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Paediatric uveitis Amsparity is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Hefiya · authorised · biosimilar · Sandoz GmbH · authorised 26 July 2018
  Indication (EMA text)

  Rheumatoid arthritis Hefiya in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hefiya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hefiya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Hefiya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Hefiya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Hefiya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Paediatric plaque psoriasis Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Hefiya is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Hefiya is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hefiya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric ulcerative colitis Hefiya is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Ulcerative colitis Hefiya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hefiya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hefiya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Hukyndra · authorised · biosimilar · Stada Arzneimittel AG · authorised 15 November 2021
  Indication (EMA text)

  Rheumatoid arthritis Hukyndra in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hukyndra in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more DMARD. Hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hukyndra is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Hukyndra is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Hukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Hukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Hukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hukyndra is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Hukyndra is indicated for the treatment of active moderate to severe HS (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Hukyndra is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hukyndra is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Hukyndra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Hukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hukyndra is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Hulio · authorised · biosimilar · Biosimilar Collaborations Ireland Limited · authorised 17 September 2018
  Indication (EMA text)

  Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hulio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Paediatric plaque psoriasis Hulio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Paediatric Crohn's disease Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric Uveitis Hulio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Humira · authorised · reference medicine · AbbVie Deutschland GmbH & Co. KG · authorised 8 September 2003
  Indication (EMA text)

  Please refer to the product information document.

• Hyrimoz · authorised · biosimilar · Sandoz GmbH · authorised 26 July 2018
  Indication (EMA text)

  Rheumatoid arthritis Hyrimoz in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis - Polyarticular juvenile idiopathic arthritis Hyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Adalimumab has not been studied in patients aged less than 2 years. - Enthesitis-related arthritis Hyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis - Ankylosing spondylitis (AS) Hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - Axial spondyloarthritis without radiographic evidence of AS Hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Hyrimoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric ulcerative colitis Hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Ulcerative colitis Hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Idacio · authorised · biosimilar · Fresenius Kabi Deutschland GmbH · authorised 2 April 2019
  Indication (EMA text)

  Rheumatoid arthritis Idacio in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Idacio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Idacio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Idacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Idacio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Idacio is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Idacio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric Uveitis Idacio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Imraldi · authorised · biosimilar · Samsung Bioepis NL B.V. · authorised 24 August 2017
  Indication (EMA text)

  Rheumatoid arthritis Imraldi in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Imraldi in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Imraldi is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Imraldi is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Imraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Imraldi is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function. Psoriasis Imraldi is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Imraldi is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Imraldi is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Imraldi is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have Ulcerative colitis Imraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Imraldi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Imraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. Paediatric Uveitis Imraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Libmyris · authorised · biosimilar · Stada Arzneimittel AG · authorised 12 November 2021
  Indication (EMA text)

  Rheumatoid arthritis Libmyris in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Libmyris in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more DMARD. Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Libmyris is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis Ankylosing spondylitis (AS) Libmyris is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Libmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Libmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Libmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Libmyris is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Libmyris is indicated for the treatment of active moderate to severe HS (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Libmyris is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Libmyris is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Libmyris is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Libmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Libmyris is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Libmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Yuflyma · authorised · biosimilar · Celltrion Healthcare Hungary Kft. · authorised 11 February 2021
  Indication (EMA text)

  Rheumatoid arthritis Yuflyma in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Yuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Yuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Yuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Yuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Yuflyma is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Yuflyma is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Yuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Yuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Yuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Yuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Cyltezo · withdrawn · biosimilar · Boehringer Ingelheim International GmbH · authorised 10 November 2017 · ended 15 January 2019 additional monitoring
  Indication (EMA text)

  Please refer to section 4.1 of the Summary of product characteristics in the product information document.

• Fyzoclad · application withdrawn · reference medicine · Pfizer Europe MA EEIG
  Indication (EMA text)

  Treatment of juvenile idiopathic arthritis, paediatric plaque psoriasis, paediatric uveitis

• Halimatoz · withdrawn · biosimilar · Sandoz GmbH · authorised 26 July 2018 · ended 18 December 2020 additional monitoring
  Indication (EMA text)

  Rheumatoid arthritis Halimatoz in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Halimatoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Halimatoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis Ankylosing spondylitis (AS) Halimatoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Halimatoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Halimatoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Halimatoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Halimatoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Halimatoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Halimatoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Halimatoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis/ Uveitis/ Paediatric uveitis For full indication see 4.1.

• Kromeya · withdrawn · biosimilar · Fresenius Kabi Deutschland GmbH · authorised 2 April 2019 additional monitoring
  Indication (EMA text)

  Rheumatoid arthritis Kromeya in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Kromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Kromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Kromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Kromeya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Kromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Kromeya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Crohn’s disease Kromeya is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Kromeya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Kromeya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Kromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric Uveitis Kromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• Solymbic · withdrawn · biosimilar · Amgen Europe B.V. · authorised 22 March 2017 · ended 15 June 2018 additional monitoring
  Indication (EMA text)

  Please refer to section 4.1 of the Summary of product characteristics in the product information document.

European Medicines Agency list of 09/10/2026 - 18:00 [5].

PubMed counts 13,644 papers on this medicine [8]. The selection gives the most recent of each type; the Method page says how it is made. See the search in PubMed ↗

Cochrane reviews (44)

• Thomas J, et al. Disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis after failure of biologic or targeted synthetic therapy: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2026. PubMed 42440279 ↗ doi ↗
• Gordon M, et al. Biologic drugs for induction and maintenance of remission in Crohn's disease: a network meta-analysis. Cochrane Database Syst Rev. 2026. PubMed 42333672 ↗ doi ↗
• Sbidian E, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2025. PubMed 40767824 ↗ doi ↗
• Sepúlveda A, et al. Tumor necrosis factor-alpha antagonists for treatment of pediatric Crohn's disease. Cochrane Database Syst Rev. 2025. PubMed 40747801 ↗ doi ↗
• Hasskamp J, et al. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025. PubMed 40357993 ↗ doi ↗

All 44 results in PubMed ↗

SMR: actual clinical benefit. ASMR: improvement in actual clinical benefit, from I (major) to V (none). Opinions taken from the BDPM [6].

• CT-19533 · 15 March 2023 · Réévaluation SMR et ASMR · SMR Important · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par HUMIRA (adalimumab) devient important dans l’indication de son AMM.

• CT-18801 · 14 December 2022 · Réévaluation suite à résultats étude post-inscript · SMR Important · ASMR Commentaires sans chiffrage de l'ASMR · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par HUMIRA (adalimumab) reste important dans le traitement de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués.

  ASMR : La Commission estime que les nouvelles données ne sont pas de nature à modifier l’appréciation de l’amélioration du service médical rendu formulée dans l’avis précédent du 24 juillet 2013.

• CT-18987 · 19 May 2021 · Extension d'indication · SMR Important · ASMR V · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par HUMIRA (adalimumab) est important dans cette extension d’indication de l’AMM dans le traitement de la RCH chez l’enfant à partir de 6 ans et l’adolescent.

  ASMR : Compte tenu : • de la faible qualité de la démonstration de l’efficacité clinique de l’adalimumab (HUMIRA) dans cette indication basée sur les résultats d’une étude non comparative (après amendement au protocole) et sur une comparaison à un placebo externe dont les résultats ne sont pas interprétables, • de l’absence de donnée comparative versus infliximab (REMICADE et ses biosimilaires), autre anti-TNF disposant d’une AMM, alors que cette comparaison était possible, mais prenant en compte : • l’intérêt potentiel de disposer d’une forme sous-cutanée chez l’enfant et, • le profil d’efficacité et de tolérance établi de l’adalimumab chez l’adulte et dans d’autres indications pédiatriques notamment la maladie de Crohn, la Commission de la Transparence considère qu’HUMIRA (adalimumab) n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie de prise en charge de la RCH active modérée à sévère chez les enfants et les adolescents à partir de 6 ans ayant eu une réponse inadéquate au traitement conventionnel, comprenant les corticoïdes et/ou l’azathioprine (AZA) ou la 6-mercaptopurine (6-MP), ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués.

• CT-19118 · 5 May 2021 · Réévaluation suite à résultats étude post-inscript · SMR Important · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par les spécialités HUMIRA 40 et 80 mg (adalimumab), solution injectable en seringue préremplie et en stylo prérempli devient important dans l’indication de l’AMM.

• CT-18876 · 3 March 2021 · Réévaluation SMR et ASMR · SMR Faible · ASMR V · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par HUMIRA (adalimumab) 40 mg/0,4 ml et 80 mg/0,8 ml, solution injectable en seringue préremplie et en stylo prérempli est faible dans l’indication de l’AMM.

  ASMR : Compte tenu : • de la démonstration d’une supériorité de l’adalimumab versus placebo dans une nouvelle étude de phase IV, sur un critère de jugement déjà jugé comme peu pertinent, à savoir la réduction du nombre de lésions inflammatoires évalué par le score Hi-SCR après 12 semaines de traitement, chez des adultes ayant une hidrosadénite suppurée active modérée à sévère candidats à la chirurgie, et avec une quantité d’effet modeste . • de l’absence de démonstration d’un impact sur le recours à la chirurgie programmée (annulation ou réduction de son étendue), critère plus cliniquement pertinent, • d’un profil de tolérance à moyen terme marqué par la survenue d’infections graves et opportunistes, de tumeurs malignes dans cette pathologie au risque infectieux et oncogène non négligeable . • de l’absence de bénéfice démontré en termes de qualité de vie, pourtant particulièrement altérée dans les formes sévères de cette maladie, • et malgré le besoin médical identifié en cas de réponse insuffisante de l’antibioprophylaxie, la Commission de la Transparence considère que HUMIRA (adalimumab), n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie de prise en charge de l’hidrosadénite suppurée.

• CT-17996 · 4 December 2019 · Modification des conditions d'inscription (CT) · SMR Insuffisant, Modéré · ASMR V · IMRALDI
  Wording of the opinion, in French

  SMR : Le service médical rendu par IMRALDI est identique à celui d’HUMIRA dans cette extension d’indication, à savoir insuffisant pour justifier d’une prise en charge par la solidarité nationale dans les autres cas d’uvéite antérieure chronique non infectieuse.

  SMR : Le service médical rendu par IMRALDI est identique à celui d’HUMIRA dans cette extension d’indication, à savoir modéré, en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié.

  ASMR : En tant que médicament biosimilaire, IMRALDI n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la biothérapie de référence, HUMIRA, en association au méthotrexate dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié.

• CT-17904 · 20 November 2019 · Inscription (CT) · SMR Important, Insuffisant, Modéré · ASMR V · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par HUMIRA 80 mg, solution injectable en stylo prérempli (B/3) est important dans le traitement : • de la polyarthrite rhumatoïde modérément à sévèrement active de l'adulte lorsque la réponse aux traitements de fond, y compris le méthotrexate est inadéquate. Humira peut être donné en monothérapie en cas d’intolérance au méthotrexate ou lorsque la poursuite du traitement avec le méthotrexate est inadaptée . • du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : o un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie o et une forme étendue et/ou un retentissement psychosocial important . • de la maladie de Crohn active, modérée à sévère chez l'adulte . • de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués . • de la rectocolite hémorragique de l’adulte . • de l’uvéite de l’adulte.

  SMR : Le service médical rendu par HUMIRA 80 mg, solution injectable en stylo prérempli (B/3) est insuffisant pour justifier d’une prise en charge par la solidarité nationale dans : • le traitement de la polyarthrite rhumatoïde sévère, en association au méthotrexate, active et évolutive chez les adultes non précédemment traités par le méthotrexate . • le traitement du psoriasis en plaques de l’adulte, pour les autres patients ne répondant pas à ces critères de mise sous traitement . • le traitement de l’hidrosadénite suppurée. • les autres cas d’uvéites antérieures chroniques non infectieuses de l’enfant à partir de 2 ans et de l’adolescent.

  SMR : Le service médical rendu par HUMIRA 80 mg, solution injectable en stylo prérempli (B/3) est modéré, en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié.

  ASMR : Cette présentation est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites.

• CT-17766 · 26 June 2019 · Inscription (CT) · SMR Important, Insuffisant, Modéré, Non précisé · ASMR V · IDACIO
  Wording of the opinion, in French

  SMR : Le service médical rendu par les présentations IDACIO est important dans l’indication de l’AMM dans le traitement : • de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans) . et uniquement pour les présentations en seringue et stylos préremplis dans le traitement : • de la spondylarthrite ankylosante, • du rhumatisme psoriasique, • de la maladie de Crohn active chez l'adulte • de la rectocolite hémorragique de l’adulte, • de l’uvéite de l’adulte. Aussi, le service médical rendu par les présentations IDACIO est important dans un périmètre restreint dans le traitement : • de la polyarthrite rhumatoïde en cas de réponse inadéquate aux traitements de fond, y compris le méthotrexate (uniquement présentations en seringue et stylos préremplis). • du psoriasis en plaques de l’enfant à partir de 4 ans et adolescent (pour l’adulte les uniquement présentations en seringue et stylos préremplis), chez les patients ayant un psoriasis en plaques chronique sévère, défini par : o un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, o et une forme étendue et/ou un retentissement psychosocial important, • de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués.

  SMR : Le service médical rendu par IDACIO, présentations en seringue et stylos préremplis, est insuffisant dans le traitement : de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate . du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement . de l’hidrosadénite suppurée de l’adulte . des autres cas d’uvéite antérieure chronique non infectieuse de l’enfant et l’adolescent. Le service médical rendu par IDACIO, présentation en flacon, est insuffisant dans le traitement : du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement . des autres cas d’uvéite antérieure chronique non infectieuse de l’enfant et l’adolescent.

  SMR : Le service médical rendu par les spécialités IDACIO est modéré dans un périmètre restreint en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié.

  SMR : Le service médical rendu par les spécialités IDACIO n’a pas été évalué dans le traitement de l'hidrosadénite suppurée chez les adolescents à partir de 12 ans car l’inscription dans cette indication n’a pas été sollicitée pour la spécialité de référence HUMIRA.

  ASMR : En tant que médicament biosimilaire, les spécialités IDACIO n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport à la spécialité de référence HUMIRA.

• CT-17555 · 6 February 2019 · Inscription (CT) · SMR Important, Insuffisant · ASMR V · IMRALDI
  Wording of the opinion, in French

  SMR : Le service médical rendu est important dans l’indication de l’AMM dans le traitement : • de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans), • de la spondylarthrite ankylosante, • du rhumatisme psoriasique, • de la maladie de Crohn active chez l'adulte • de la rectocolite hémorragique de l’adulte, • de l’uvéite de l’adulte. Le service médical rendu est important dans un périmètre restreint dans le traitement : • de la polyarthrite rhumatoïde en cas de réponse inadéquate aux traitements de fond, y compris le méthotrexate, • du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : o un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, o et une forme étendue et/ou un retentissement psychosocial important, • du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : o un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, o et une forme étendue et/ou un retentissement psychosocial important, • de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués,

  SMR : Le service médical rendu est insuffisant dans le traitement : • de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate, • du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement, • de l’hidrosadénite suppurée.

  ASMR : Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites.

• CT-17415 · 21 November 2018 · Inscription (CT) · SMR Important, Insuffisant, Modéré · ASMR V · HULIO
  Wording of the opinion, in French

  SMR : Le service médical rendu par cette spécialité est important dans un périmètre restreint dans le traitement : • de la polyarthrite rhumatoïde en cas de réponse inadéquate aux traitements de fond, y compris le méthotrexate, • du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, et une forme étendue et/ou un retentissement psychosocial important, • du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, et une forme étendue et/ou un retentissement psychosocial important, • de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués,

  SMR : Le service médical rendu par cette spécialité est insuffisant dans le traitement : • de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate, • du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement, • de l’hidrosadénite suppurée de l’adulte, • des autres cas d’uvéite antérieure chronique non infectieuse de l’enfant et l’adolescent.

  SMR : Le service médical rendu par cette spécialité est modéré dans un périmètre restreint : • en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié.

  SMR : Le service médical rendu par cette spécialité est important dans l’indication de l’AMM dans le traitement : • de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans), Le service médical rendu est important dans un périmètre restreint dans le traitement : • du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, et une forme étendue et/ou un retentissement psychosocial important, • de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués,

  SMR : Le service médical rendu par cette spécialité est insuffisant dans le traitement : • du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement, • des autres cas d’uvéite antérieure chronique non infectieuse de l’enfant et l’adolescent.

  SMR : Le service médical rendu par cette spécialité est modéré dans un périmètre restreint : • en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié

  ASMR : En tant que médicament biosimilaire, HULIO n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la biothérapie de référence, HUMIRA.

• CT-17068 · 11 July 2018 · Inscription (CT) · SMR Important, Insuffisant · ASMR V · IMRALDI
  Wording of the opinion, in French

  SMR : Le service médical rendu est important dans le traitement : • de la polyarthrite rhumatoïde modérément à sévèrement active de l'adulte lorsque la réponse aux traitements de fond, y compris le méthotrexate est inadéquate, en association au méthotrexate. IMRALDI peut être donné en monothérapie en cas d'intolérance au méthotrexate ou lorsque la poursuite du traitement avec le méthotrexate est inadaptée. • de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans) . • de la spondylarthrite ankylosante sévère et active chez l’adulte ayant eu une réponse inadéquate au traitement conventionnel et de la spondyloarthrite axiale sévère sans signes radiographiques de SA, • du rhumatisme psoriasique actif et évolutif chez les adultes lorsque la réponse à un traitement de fond antérieur a été inadéquate, • du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, • du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère, • de la maladie de Crohn active, modérée à sévère chez l'adulte . • de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués. • de la rectocolite hémorragique de l’adulte, • de l’uvéite de l’adulte.

  SMR : Le service médical rendu est insuffisant dans le traitement : • de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate, • du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement, • de l’hidrosadénite suppurée

  ASMR : En tant que médicament biosimilaire, IMRALDI n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la biothérapie de référence, HUMIRA.

• CT-16979 · 11 July 2018 · Inscription (CT) · SMR Important, Insuffisant · ASMR V · AMGEVITA
  Wording of the opinion, in French

  SMR : Le service médical rendu est important dans le traitement : • de la polyarthrite rhumatoïde modérément à sévèrement active de l'adulte lorsque la réponse aux traitements de fond, y compris le méthotrexate est inadéquate, en association au méthotrexate. AMGEVITA peut être donné en monothérapie en cas d'intolérance au méthotrexate ou lorsque la poursuite du traitement avec le méthotrexate est inadaptée, • de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans), • de la spondylarthrite ankylosante sévère et active chez l’adulte ayant eu une réponse inadéquate au traitement conventionnel et de la spondyloarthrite axiale sévère sans signes radiographiques de SA, • du rhumatisme psoriasique actif et évolutif chez les adultes lorsque la réponse à un traitement de fond antérieur a été inadéquate, • du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, • du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère, • de la maladie de Crohn active, modérée à sévère chez l'adulte, • de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués, • de la rectocolite hémorragique de l’adulte, • de l’uvéite de l’adulte.

  SMR : Le service médical rendu est insuffisant dans le traitement : • de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate (en association au méthotrexate), • du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement, • de l’hidrosadénite suppurée

  ASMR : En tant que médicament biosimilaire, AMGEVITA n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la biothérapie de référence, HUMIRA.

• CT-16061 · 11 July 2018 · Extension d'indication non sollicitée · SMR Non précisé · HUMIRA
  Wording of the opinion, in French

  SMR : Le laboratoire ne demande pas l’inscription dans « le traitement de l’hidrosadéniste suppurée (maladie de Verneuil) active, modérée à sévère, chez les adolescents à partir de 12 ans en cas de réponse insuffisante au traitement systémique conventionnel de l’HS ». De ce fait ces spécialités ne sont pas remboursables ni agréées aux collectivités dans cette indication. .

• CT-16820 · 13 June 2018 · Extension d'indication · SMR Insuffisant, Modéré · ASMR IV · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par HUMIRA est insuffisant pour justifier d’une prise en charge par la solidarité nationale dans les autres cas d’uvéite antérieure chronique non infectieuse.

  SMR : Le service médical rendu par HUMIRA est modéré, en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié .

  ASMR : Compte tenu de : • la démonstration de la supériorité d’adalimumab en association au méthotrexate, par rapport au placebo sur le délai la survenue d’une nouvelle poussée inflammatoire (étude SYCAMORE), critère de jugement pertinent dans cette maladie, • des critères d’inclusion des études restreignant la population aux patients ayant une arthrite juvénile idiopathique associée à leur uvéite, • des incertitudes sur la réelle quantité d’effet du fait de nombreux biais méthodologiques (nombre important de violations majeures au protocole et arrêt prématuré de l’étude SYCAMORE), • de l’absence de démonstration d’un impact sur la qualité de vie, • et des incertitudes sur l’efficacité et la tolérance à long terme, la Commission considère qu’HUMIRA en association au méthotrexate apporte une amélioration du service médical rendu mineure (ASMR IV) dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié.

• CT-15576 · 25 January 2017 · Extension d'indication · SMR Important · ASMR IV · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par HUMIRA est important dans l’extension d'indication : traitement de l’uvéite non infectieuse, intermédiaire, postérieure et de la panuvéite chez les patients adultes ayant eu une réponse insuffisante à la corticothérapie, chez les patients nécessitant une épargne cortisonique, ou chez lesquels la corticothérapie est inappropriée.

  ASMR : Compte tenu : • de la démonstration de la supériorité de l’adalimumab par rapport au placebo sur le pourcentage de patients ayant eu une rechute à partir de la 6ème semaine de traitement chez des patients atteints d’uvéite non infectieuse intermédiaire, postérieure ou de panuvéite non infectieuse en échec à la corticothérapie ou corticodépendante, • de la confirmation de cette efficacité en pratique réelle en termes de réponse complète et de rechute, • mais de la quantité d’effet modérée, • des données de tolérance, • de l’absence de comparateur cliniquement pertinent, • de l’absence de données d’efficacité et de tolérance à long terme et de démonstration d’un impact sur la qualité de vie, la Commission considère que HUMIRA apporte une amélioration du service médical rendu mineure (ASMR IV) dans le traitement de l’uvéite non infectieuse, intermédiaire, postérieure et de la panuvéite non infectieuse chez les patients adultes ayant eu une réponse insuffisante à la corticothérapie, chez les patients nécessitant une épargne cortisonique, ou chez lesquels la corticothérapie est inappropriée.

• CT-15008 · 22 June 2016 · Inscription (CT) · SMR Important, Insuffisant · ASMR V · HUMIRA
  Wording of the opinion, in French

  SMR : Le service médical rendu par HUMIRA 40 mg/0,4 mL, solution injectable en seringue préremplie et en stylo prérempli est important dans le traitement de : • la polyarthrite rhumatoïde modérément à sévèrement active de l'adulte lorsque la réponse aux traitements de fond, y compris le méthotrexate, est inadéquate. • l’arthrite juvénile idiopathique o arthrite juvénile idiopathique polyarticulaire o arthrite liée à l’enthésite • la spondyloarthrite axiale chez l’adulte o spondylarthrite ankylosante (SA) o spondyloarthrite axiale sans signes radiographiques de SA • le rhumatisme psoriasique chez l’adulte • la maladie de Crohn chez l’adulte • la maladie de Crohn chez l'enfant et l’adolescent • la rectocolite hémorragique chez l’adulte • le psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : o un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie o et une forme étendue et/ou un retentissement psychosocial important. Dans le traitement de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate, le service médical rendu reste important dans l’attente de sa réévaluation par la Commission de la transparence.

  SMR : Le service médical rendu par HUMIRA 40 mg/0,4 mL, solution injectable en seringue préremplie et en stylo prérempli est insuffisant dans le traitement : • du psoriasis en plaques de l’adulte, pour les autres patients ne répondant pas à ces critères de mise sous traitement • de l’hidrosadénite suppurée.

  ASMR : Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites.

• TA715 · Adalimumab , etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed · 14 July 2021 · published
• TA460 · Adalimumab and dexamethasone for treating non-infectious uveitis · 26 July 2017 · published
• TA455 · Adalimumab , etanercept and ustekinumab for treating plaque psoriasis in children and young people · 12 July 2017 · published
• TA392 · Adalimumab for treating moderate to severe hidradenitis suppurativa · 22 June 2016 · published
• TA375 · Adalimumab , etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed · 26 January 2016 · published
• TA373 · Abatacept, adalimumab , etanercept and tocilizumab for treating juvenile idiopathic arthritis · 16 December 2015 · published
• TA329 · Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy · 25 February 2015 · published
• TA199 · Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis · 25 August 2010 · published
• TA195 · Adalimumab , etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor · 25 August 2010 · published
• TA187 · Infliximab and adalimumab for the treatment of Crohn's disease · 19 May 2010 · published
• TA146 · Adalimumab for treating moderate to severe plaque psoriasis · 25 June 2008 · published
• TA125 · Adalimumab for the treatment of psoriatic arthritis
• TA143 · Adalimumab , etanercept and infliximab for ankylosing spondylitis
• TA130 · Adalimumab , etanercept and infliximab for the treatment of rheumatoid arthritis
• TA262 · Adalimumab for the treatment of moderate to severe ulcerative colitis (terminated appraisal)
• NICE list [9]

• SMC 1305/18 · 15 January 2018 · adalimumab (Humira) · not recommended · Non submission
  Indication

  Treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

• SMC 1243/17 · 12 June 2017 · adalimumab (Humira) · accepted · Abbreviated
  Indication

  for treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.

• SMC 1208/16 · 7 November 2016 · adalimumab (Humira) · not recommended · Non submission
  Indication

  Treatment of moderately active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies

• SMC 1209/16 · 7 November 2016 · adalimumab (Humira) · superseded · Non submission
  Indication

  Treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

• SMC 1173/16 · 11 July 2016 · adalimumab (Humira) · not recommended · Non submission
  Indication

  Treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. (This licence extension relates to previous SMC advice (468/08).

• SMC 1143/16 · 9 May 2016 · adalimumab (Humira) · accepted · Full
  Indication

  Treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.

• SMC 1068/15 · 13 July 2015 · adalimumab (Humira) · superseded · Abbreviated
  Indication

  Treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

• SMC 1050/15 · 11 May 2015 · adalimumab (Humira) · restricted · Abbreviated
  Indication

  For the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.

• SMC 881/13 · 8 July 2013 · adalimumab (Humira) · superseded · Abbreviated
  Indication

  In combination with methotrexate for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 2 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in children aged less than 2 years.

• SMC 880/13 · 8 July 2013 · adalimumab (Humira) · restricted · Abbreviated
  Indication

  For the treatment of severe active Crohn's disease in paediatric patients (6 to 17 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.

• SMC 858/13 · 8 April 2013 · adalimumab (Humira) · superseded · Full
  Indication

  For the treatment of adults with severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis (nr-axSpA) but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

• SMC 824/12 · 12 November 2012 · adalimumab (Humira) · not recommended · Non submission
  Indication

  Treatment of moderately active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

• SMC 800/12 · 9 July 2012 · adalimumab (Humira) · superseded · Non submission
  Indication

  Treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

• SMC 738/11 · 7 November 2011 · adalimumab (Humira) · superseded · Abbreviated
  Indication

  In combination with methotrexate for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 4 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in children aged less than 4 years.

• SMC 533/09 · 9 February 2009 · adalimumab (Humira) · superseded · Abbreviated
  Indication

  Active polyarticular juvenile idiopathic arthritis in adolescents

• SMC 468/08 · 9 June 2008 · adalimumab (Humira) · restricted · Full
  Indication

  Moderate to severe chronic plaque psoriasis in adult patients

• SMC 417/07 · 12 November 2007 · adalimumab 40mg solution for injection (Humira) · superseded · Full
  Indication

  Severe active crohn' s disease

• SMC 300/06 · 11 December 2006 · adalimumab 40mg pre-filled syringe (Humira) · superseded · Full
  Indication

  Severe active ankylosing spondylitis

• SMC 218/05 · 12 December 2005 · adalimumab (Humira) · superseded · Full
  Indication

  active and progressive psoriatic arthritis.

• SMC 81/03 · 8 December 2003 · adalimumab (Humira) · superseded · Full
  Indication

  Rheumatoid arthritis

• SMC advice [10]

The G-BA has run no early benefit assessment (AMNOG) of this medicine on its own [11].

The AEMPS database of therapeutic positioning reports holds no report on this medicine [12].