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Hukyndra (adalimumab)

Biosimilar
Region
🇪🇺 EU
Active substance
adalimumab
Company
Stada Arzneimittel AG
Status
Authorised
Therapeutic area
Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
CHMP opinion
Thu 16 Sep 2021
EU approval
Mon 15 Nov 2021
Designations
Biosimilar
Application
EMEA/H/C/005548
ATC
L04AB04
Official record
www.ema.europa.eu

Indication

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 r

Regulatory milestones

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