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FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

INCHEON, Korea – November 19, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing AVASTIN®  (bevacizumab). The BLA for SB8 was submitted by Samsung Bioepis in September 2019. 

If approved, SB8 will be commercialized in the United States (US) by Merck & Co., Inc., Kenilworth, NJ, USA, which is known as MSD outside the US and Canada.

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology and gastroenterology. For more information, please visit: and follow us on social media– Twitter, LinkedIn.

i) AVASTIN® is a registered trademark of Genentech Inc.