FDA approves Hyrimoz (adalimumab biosimilar). Sandoz.

Sandoz, a Novartis division and the pioneer and global leader in biosimilars, announced that the FDA approved its biosimilar, Hyrimoz (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn's disease (CD), ulcerative colitis (UC) and plaque psoriasis (Ps).

The FDA approval of Hyrimoz was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz matches the reference biologic in terms of safety, efficacy and quality. A randomized, double-blind, three-arm, parallel biosimilarity study confirmed the pharmacokinetics, immunogenicity and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A confirmatory efficacy and safety biosimilarity study (ADACCESS) demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic.

Comment: The patents on Humira expired in the US in November 2017 and in Europe in June 2017.