BRIEF—FDA accepts Samsung Bioepis' oncology biosimilar for review

Samsung Bioepis has had its Biologics License Application for SB3, a biosimilar referencing Roche’s big-selling cancer drug Herceptin (trastuzumab), accepted by the US Food and Drug Administration.

SB3 is the first oncology biosimilar candidate submitted for regulatory review in the USA by Samsung Bioepis, a joint venture between Korean conglomerate Samsung and US biotech Biogen.

If approved, SB3 will be commercialized in the USA by Merck & Co.

Samsung Bioepis had its Herceptin copy approved by the European Commission in November 2017, and it will be sold there under the name Ontruzant.