On November 19, 2019 Samsung Bioepis Co., Ltd. reported 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 AVASTINi (bevacizumab) (Press release, Samsung Bioepis, NOV 19, 2019, View Source [SID1234551481]). The BLA for SB8 was submitted by Samsung Bioepis in September 2019.

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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.