Flixabi biosimilar infliximab regulatory update

EMA’s CHMP recommended approval of Flixabi infliximab, a biosimilar of Remicade infliximab, from Samsung Bioepis Co. Ltd. to treat rheumatoid arthritis (RA), Crohn’s disease (CD), ulcerative colitis (UC), ankylosing spondylitis, psoriatic arthritis and psoriasis. In 2013, Merck partnered with Samsung Bioepis, a JV between Biogen and Samsung Biologics, to develop and commercialize multiple biosimilars, including Flixabi. Merck has worldwide rights to the biosimilar outside of the EU, Russia and Turkey, while Biogen has EU commercialization rights. Samsung Biologics is a JV between Samsung Group and Quintiles Transnational Corp. (NYSE:Q, Research Triangle Park, N.C.). ...