Information on Biosimilars

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 Cyltezo (adalimumab-adbm) for multiple indications. Cyltezo is administered by injection. This is the second FDA-approved biosimilar to U.S.-licensed Humira. For more information, see the labeling atDrugs@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 please visit: Biosimilars.