ARTICLE | Clinical News
Sandoz: Biosimilar matches Enbrel in switching study
November 22, 2016 11:41 PM UTC
The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said there were "no clinically meaningful differences" between the safety or efficacy of its biosimilar Erelzi etanercept-szzs and reference product Enbrel etanercept after 52 weeks in the Phase III EGALITY switching study to treat plaque psoriasis.
Amgen Inc. (NASDAQ:AMGN) markets Enbrel. In August, FDA approved Erelzi for all indications included on Enbrel's label. Sandoz has yet to market the biosimilar in the U.S. To do so, it must win pending litigation or wait until Amgen's Enbrel patents expire in 2029 (see BioCentury Extra, Aug. 30)...