Posted by Michael Wonder on 21 Dec 2017
Samsung Bioepis’ SB3 trastuzumab biosimilar candidate accepted for review by the US FDA
20 December 2017 - Samsung Bioepis today announced that the US FDA has accepted for review the company’s biologics license application under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin (trastuzumab).
SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the US. If approved, SB3 will be commercialised in the US by Merck, which is known as MSD outside of the US and Canada.
