EMA backs new adalimumab biosimilar
medwireNews: The European Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of the adalimumab biosimilar GP2017 for the treatment of various rheumatic diseases.
The biosimilar will be marketed under three brand names; Hyrimoz and Halimatoz are indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), axial spondyloarthritis, and psoriatic arthritis (PsA), as well as other conditions including psoriasis and uveitis. Hefiya is also recommended for patients with JIA, axial spondyloarthritis, and PsA, but the list of indications does not include RA.
As with the originator product, GP2017 will be available as a 40 mg solution for subcutaneous injection.
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