Biosimilar adalimumab regulatory update

FDA’s Arthritis Advisory Committee voted unanimously to recommend approval of a BLA from Amgen for ABP 501, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NYSE:ABBV, Chicago, Ill.). The action date under the Biosimilar User Fee Act (BsUFA) is Sept. 25. Amgen is seeking approval for all of the indications on Humira’s label except those covered by Orphan drug exclusivity. Amgen is seeking approval for rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, active ankylosing spondylitis, Crohn’s disease (CD), ulcerative colitis (UC) and chronic plaque psoriasis. Humira is a human mAb against tumor necrosis factor (TNF) alpha. ...