FDA approves Amgen's Amjevita as a biosimilar to Humira

The US Food and Drug Administration has approved biotech major Amgen’s (Nasdaq: AMGN) Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab), making this only the fourth biosimilar to be approved by the agency so far.

Amjevita is the first adalimumab biosimilar approved by the FDA and has been cleared for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. Amjevita is Amgen's first biosimilar to receive regulatory approval.

Last month, AbbVie (NYSE: ABBV), the maker of the mega-blockbuster Humira, filed a patent-infringement lawsuit against Amgen, seeking to block sales of the biosimilar.