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FDA panel backs Sandoz's biosimilar Enbrel
July 14, 2016 12:30 AM UTC
On Wednesday, FDA's Arthritis Advisory Committee voted unanimously to recommend approval of GP2015 from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN), a biosimilar version of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN).
The advisory committee supported Sandoz's request for approval in all of Enbrel's indications: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. ...