FDA nod for biosimilar Hyrimoz high-concentration formulation

Sandoz, the soon to be spun-out generics and biosimilars unit of Swiss pharma giant Novartis (NOVN: VX), today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection.

The adalimumab citrate-free HCF (100mg/mL) is approved to treat seven indications covered by the reference medicine Humira (adalimumab), a mega blockbuster product marketed by AbbVie (NYSE: AB BV), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

Launch set for July 1