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FDA approves Amgen's biosimilar of Humira

September 23, 2016 7:00 AM UTC

FDA approved Amjevita adalimumab-atto ( ABP 501) from Amgen Inc. (NASDAQ:AMGN), a biosimilar of Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). The agency approved Amjevita for all indications Amgen had sought: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis and polyarticular juvenile idiopathic arthritis. It is the fourth biosimilar FDA has approved, and the first biosimilar of Humira. Amjevita is also under EMA review.

In a lawsuit filed last month, AbbVie alleged Amjevita infringes 10 Humira patents and sought an injunction preventing its launch. Amgen has said that it could launch the biosimilar as soon as 2017, while AbbVie has countered that its Humira patent portfolio is strong enough to keep Humira biosimilars off the U.S. market until 2022 (see BioCentury, July 25). ...