FDA Approves Remicade Biosimilar Without Advisory Panel, Follows Controversial Naming Convention

FDA announced Friday (April 21) approval of Samsung Bioepsis Co LTD's biosimilar for Remicade, which appears to be the first biosimilar approved without an advisory committee weighing in, as well as the first biologic product to follow FDA's biologic naming scheme after the agency finalized the convention in January. “FDA today approved Renflexis (infliximab-abda) for multiple indications. Renflexis is administered by intravenous infusion. This is the second FDA-approved biosimilar to U.S.-licensed Remicade,” an FDA press release announcing the approval states...