On 18 December 2020, the European Commission withdrew the marketing authorisation for Halimatoz (adalimumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sandoz GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Halimatoz was granted marketing authorisation in the EU on 26 July 2018 for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, uveitis and paediatric uveitis. The marketing authorisation was initially valid for a 5\-year period. The product has never been marketed in the EU. Halimatoz is a biosimilar of Humira. There are other biosimilar medicinal products of Humira authorised and marketed in the EU. The European Public Assessment Report (EPAR) for Halimatoz is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic Indication
**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\.
Therapeutic Area (MeSH)
ATC Code
L04AB04
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
EMA Name
Halimatoz
Medicine Name
Halimatoz
Aliases
N/ANo risk management plan link.
