The latest news about Samsung Bioepis
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.
i) AVASTIN® is a registered trademark of Genentech Inc.