Merck to Launch Ontruzant, a Herceptin Biosimilar, in US

Merck to Launch Ontruzant, a Herceptin Biosimilar, in US
Ontruzant (trastuzumab-dttb), a biosimilar to Genentech's Herceptin (trastuzumab), will now be made available in the U.S. as a treatment for HER2-overexpressing breast cancers as well as for stomach cancers, according to a press release from Merck. Merck will be launching the antibody treatment in the U.S., as part of an agreement with Samsung Bioepis, Ontruzant's developers. It will be available for the same indications as Herceptin. The U.S. Food and Drug Administration (FDA) had approved the biosimilar in January 2019 based on extensive data that showed a high degree of similarity between Ontruzant and Herceptin with regard to safety, purity, and potency. Per the agreement, Samsung Bioepis will be responsible for development and clinical trials investigating Ontruzant, while Merck will be responsible for commercialization in the U.S. and other territories. The
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