Posted by Michael Wonder on 19 Nov 2019
FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate
19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license application under the 351(k) pathway for SB8, a biosimilar candidate referencing Avastin (bevacizumab).
The application for SB8 was submitted by Samsung Bioepis in September 2019.
If approved, SB8 will be commercialised in the United States by Merck, which is known as MSD outside the US and Canada.
