FDA to discuss Amgen's Humira biosimilar

FDA's Arthritis Advisory Committee is to meet July 12 to discuss a BLA from Amgen Inc. (NASDAQ:AMGN) for ABP 501, a proposed biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV).

Amgen is seeking the biosimilar's approval to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, active ankylosing spondylitis, Crohn's disease, ulcerative colitis and chronic plaque psoriasis. Humira is a human mAb against tumor necrosis factor (TNF) alpha. ...