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US FDA accepts Samsung Bioepis' application for Herceptin biosimilar

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US FDA accepts Samsung Bioepis' application for Herceptin biosimilar

The U.S. Food and Drug Administration accepted Samsung Bioepis Co. Ltd.'s biologics license application for its biosimilar version of Roche Holding AG's breast cancer drug Herceptin.

If approved, SB3 will be commercialized in the U.S. by Merck & Co. Inc.

SB3 is Samsung Bioepis' first oncology biosimilar candidate submitted for regulatory approval in the U.S.