FDA Takes Up Application For Biosimilar Of Janssen's Remicade

FDA has accepted for review Samsung Bioepis' application for a biosimilar of Janssen's Remicade. FDA has already approved a biosimilar for the same infliximab product sponsored by Celltrion and Hospira. Samsung Bioepis filed the application as part of its partnership with Merck to offer biosimilar alternatives to existing biologic medicines. “If approved, SB2 would offer an important therapeutic option to help meet the needs of U.S. physicians, patients and the healthcare system in the treatment of certain serious inflammatory diseases,”...