FDA approves Mylan's Ogivri, a biosimilar for trastuzumab
Mylan and Biocon announced that the U.S. Food and Drug Administration has approved Mylan's Ogivri, a biosimilar to Herceptin, co-developed with Biocon. Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the U.S. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan's ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan's biosimilar to Herceptin in various markets globally.