Novartis’ Sandoz receives FDA approval for biosimilar Hyrimoz HCF

Sandoz, a Novartis division, announced that the U.S. Food and Drug Administration approved a citrate-free high-concentration formulation of its biosimilar Hyrimoz injection. The adalimumab citrate-free HCF 100 mg/mL is approved to treat seven indications covered by the reference medicine, Humira, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. Sandoz intends to launch the Hyrimoz citrate-free HCF in the U.S. on July 1, the company stated.