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FDA panel backs Amgen's biosimilar Humira

July 13, 2016 12:47 AM UTC

FDA's Arthritis Advisory Committee voted unanimously Tuesday to recommend approval of ABP 501 from Amgen Inc. (NASDAQ:AMGN), a biosimilar version of Humira adalimumab from AbbVie Inc. (NYSE:ABBV), for all of the indications on Humira's label except those covered by Orphan drug exclusivity. Amgen is seeking approval for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, active ankylosing spondylitis, Crohn's disease, ulcerative colitis and chronic plaque psoriasis.

Several committee members expressed concerns about the lack of clinical data for the inflammatory bowel disease indications. They noted that the mechanism of action for Humira's efficacy in adult ulcerative colitis and adult Crohn's disease is not well understood. Committee members with these concerns said that analytic data demonstrating ABP 501's similarity to Humira, as well as FDA's confidence about extrapolation to these indications, led them to recommend approval. ...