BioCentury
ARTICLE | Clinical News

Biosimilar etanercept regulatory update

June 13, 2016 7:00 AM UTC

FDA’s Arthritis Advisory Committee will meet on July 13 to discuss a BLA from Novartis’ Sandoz Inc. generics unit for GP2015, a biosimilar of autoimmune drug Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.) and Pfizer Inc. (NYSE:PFE, New York, N.Y.). Novartis declined to disclose the PDUFA date. The BLA covers all of Enbrel’s indications, including rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis (AS) and plaque psoriasis. ...