Mylan and Biocon Launch Herceptin (trasuzumab) Biosimilar Ogivri™ in U.S.

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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.

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