January 18, 2019 — 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.
Posted: January 2019
- Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration – December 20, 2017
Ontruzant (trastuzumab-dttb) FDA Approval History
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