FDA approves Sandoz biosimilar Hyrimoz

Adding to its European approval back in July, Sandoz, the generics business of Novartis (NOVN: VX), says that the US Food and Drug Administration has approved Hyrimoz(adalimumab-adaz), its biosimilar version of AbbVie’s (NYSE: ABBV) mega-blockbuster Humira.

The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn's disease (CD), ulcerative colitis (UC) and plaque psoriasis (Ps).

This becomes the third US FDA-approved biosimilar, and adding to market clearances for Amjevita (adalimumab-atto)from Amgen (Nasdaq: AMGN) in 2016 and Cyltezo(adalimumab-adbm), from Boehringer Ingelheim in 2017.