ARTICLE | Company News
FDA to discuss Sandoz biosimilar, Valeant's brodalumab
June 10, 2016 1:26 AM UTC
FDA scheduled advisory committee meetings to discuss BLAs for biosimilar etanercept ( GP2015) from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) and brodalumab ( KHK4827) from Valeant Pharmaceuticals International Inc. (TSX;VRX; NYSE:VRX).
The agency's Arthritis Advisory Committee is to meet July 13 to discuss Sandoz's BLA for its biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN). Sandoz is seeking approval to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, active ankylosing spondylitis and plaque psoriasis. Etanercept is a recombinant p75 tumor necrosis factor (TNF) receptor linked to the Fc portion of human IgG1 (TNFr:Fc). ...