Novartis’ Sandoz: FDA OK for rheumatoid arthritis biosimilar Hyrimoz

Sandoz, a Novartis (NVS) division, announced that the U.S. Food and Drug Administration approved its biosimilar, Hyrimoz. 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. On October 11, 2018, Sandoz announced a global resolution of all intellectual property-related litigation with AbbVie (ABBV) concerning all indications of the proposed Sandoz biosimilar adalimumab for the reference medicine. The license enables patient access in the U.S. to Hyrimoz, or Sandoz adalimumab or Sandoz biosimilar, as of September 30, 2023.

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