ARTICLE | Clinical News

Biosimilar etanercept regulatory update

July 18, 2016 7:00 AM UTC

FDA’s Arthritis Advisory Committee voted unanimously to recommend approval of GP2015, a biosimilar of autoimmune drug Enbrel etanercept, from the Sandoz unit of Novartis. The advisory committee supported Sandoz’s request for approval in all of Enbrel’s indications: rheumatoid arthritis (RA), plaque psoriasis, psoriatic arthritis, ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). Sandoz has not disclosed GP2015’s FDA user fee action date.

Separately, Novartis’ Sandoz Canada unit said Health Canada accepted for review an NDS for GP2015. Last December, EMA accepted an MAA for GP2015 (see BioCentury, Dec. 14, 2015). ...