BioCentury
ARTICLE | Company News

Samsung's Herceptin biosimilar gains U.S. approval

January 22, 2019 4:55 PM UTC

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer.

Ontruzant received approval for all eligible indications, including HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) markets Herceptin for all three indications...