ARTICLE | Clinical News

SB4 regulatory update

January 26, 2015 8:00 AM UTC

EMA accepted for review an MAA from Samsung Bioepis Co. Ltd. for SB4, a biosimilar of autoimmune drug Enbrel etanercept. Samsung Bioepis is a JV between Biogen Idec and Samsung. Biogen Idec will commercialize the biosimilar in Europe, if approved. Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.) and Pfizer Inc. (NYSE:PFE, New York, N.Y.) co-market Enbrel in the U.S. and Canada, while Pfizer has rights elsewhere. ...