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FDA approves Ontruzant (trastuzumab-dttb), 3rd biosimilar to Herceptin (trastuzumab)

firstwordpharmaJanuary 21, 2019

Tag: FDA , biosimilar , Ontruzant , FDA

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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.

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