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FDA Accepts for Review Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate

09:24 EST 21 Dec 2017 | Speciality Pharma Journal

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin® i (trastuzumab). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the United States (US). …

Original Article: FDA Accepts for Review Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate

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