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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 Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab).

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA 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. 

For more information about biosimilar products, please visit: Biosimilars

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