FDA approves Renflexis (infliximab-abda), biosimilar to Remicade- Drug Information Update

Information on Biosimilars

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA

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.  For more information, see the approval letter and the labeling at Drugs@FDA.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. For more information about biosimilar products, visit www.fda.gov/biosimilars.