Biosimilars Newsfeed
Amgen's Humira Biosimilar Accepted for FDA Review
Bloomberg BNA (01/26/16) Aquino, John T.
On Jan. 25, the U.S. Food and Drug Administration (FDA) accepted for review Amgen's application for a biosimilar of Humira (adalimumab). Humira, the top-selling drug at AbbVie, is licensed to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, adult and pediatric Crohn's disease, and ulcerative colitis. Amgen's biosimilar is named ABP 501. The company submitted a biologics license application (BLA) on Nov. 25, 2015, and FDA's decision is expected by Sept. 25. Sean E. Harper, Amgen's executive vice president of research and development, said in a statement: "If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions." Sam Fazeli, Bloomberg Intelligence's senior industry analyst, notes that AbbVie's dependence on Humira--which accounted for more than 60 percent of sales in 2014--exposes it to potential biosimilars starting in 2017, after the patents covering Humira expire this year.
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