ARTICLE | Clinical News
Amjevita biosimilar adalimumab regulatory update
October 3, 2016 7:00 AM UTC
FDA approved a BLA from Amgen for Amjevita adalimumab-atto to treat multiple inflammatory diseases. The biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV, Chicago, Ill.) is approved for all indications sought: rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, Crohn’s disease (CD), ulcerative colitis (UC), plaque psoriasis and polyarticular juvenile idiopathic arthritis. It is the first biosimilar of Humira and the fourth biosimilar FDA has approved. The biosimilar is under EMA review. ...