Biosimilar etanercept regulatory update

The European Commission approved an MAA from Samsung Bioepis Co. Ltd. for Benepali etanercept, a biosimilar of autoimmune drug Enbrel etanercept. Biogen said it plans to make Benepali available in Europe “in the coming weeks.” The biosimilar is approved to treat adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Samsung Bioepis is a JV between Biogen and Samsung Biologics, a JV between Samsung Group and Quintiles Transnational Corp. (NYSE:Q, Research Triangle Park, N.C.). ...