Posted by Michael Wonder on 31 Oct 2018
Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz)
31 October 2018 - Biosimilar Hyrimoz (adalimumab-adaz) approved for all indications of reference medicine not protected by orphan exclusivity.
Sandoz today announced that the US FDA approved its biosimilar, Hyrimoz (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.
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 randomised, 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.
