ARTICLE | Company News

EMA accepts MAA for Sandoz's Enbrel biosimilar

December 10, 2015 2:35 AM UTC

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said EMA accepted an MAA for biosimilar etanercept ( GP2015). Sandoz is seeking approval in all indications for which reference product Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN) is approved. Pfizer Inc. (NYSE:PFE) has rights to Enbrel, a recombinant p75 tumor necrosis factor (TNF) receptor linked to the Fc portion of human IgG1 (TNFrFc), outside the U.S. and Canada.

Enbrel is approved in Europe to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and non-radiographic axial spondyloarthritis. Sandoz said its submission includes two pivotal trials: a pharmacokinetic study in healthy volunteers and the EGALITY safety and efficacy study in chronic psoriasis patients. ...