Mylan and Biocon Launch Herceptin (trasuzumab) Biosimilar Ogivri™ in U.S.
Last week, Mylan and Biocon announced the U.S. launch of Ogivri™ (trasuzumab-dkst), a biosimilar to Herceptin® (trasuzumab). Genentech’s Herceptin, which was first approved in 1998, is a monoclonal antibody used to treat breast cancer and metastatic stomach cancer. Genentech and its parent company Roche had previously tried to block Ogivri™ from the U.S. market by suing for patent infringement, but Mylan, Genentech, and Roche reached a settlement in March 2017 that provided Mylan with global licenses for Ogivri™, effective on undisclosed dates. FDA then approved Ogivri™ for all of Herceptin’s indications in December 2017. Ogivri™ is the second trasuzumab biosimilar to launch this year, following Amgen’s Kanjinti™, which launched in July.