This week, Samsung Bioepis announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar of Genentech’s Herceptin (trasuzumab).  Ontruzant® will be marketed and distributed in the U.S. by Merck.  This launch represents Samsung Bioepis’s first oncology biosimilar in the U.S. market.  Genentech’s Herceptin is a monoclonal antibody used to treat breast cancer and metastatic stomach cancer, first approved in 1998.  Genentech tried to block the market entry of Ontruzant® by suing for patent infringement, but Samsung Bioepis and Genentech reached a settlement in June 2019.

Ontruzant® joins prior trasuzumab biosimilars including Mylan and Biocon’s Ogivri™, which launched in December of 2019, and Amgen’s Kanjinti™, which launched in July of 2019.