FDA approves Sandoz's third biosimilar

On Oct. 31, Sandoz, a division of Novartis, announced that the U.S. Food and Drug Administration approved its biosimilar, adalimumabadaz (Hyrimoz, Novartis AG), 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.

In clinical trials, adalimumab-adaz was shown to match the safety, efficacy and quality of its reference biologic. Adalimumab-adaz met its primary endpoint in a randomized, double-blind, three-arm, parallel study confirming its pharmacokinetics, immunogenicity and safety. A follow-up study demonstrated therapeutic equivalence in patients with moderate to severe chronic plaque-type psoriasis.

Adalimumab-adaz is the third FDA-approved biosimilar for Sandoz in the U.S.