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USFDA has given approval to Mylan’s Ogivri, which is a biosimilar of cancer drug Herceptin, co-developed with Biocon. Trastuzumab is the generic name of Herceptin.
Ogivri has received approval from the regulator, for all indications of the reference product, Herceptin, including for the treatment of HER2 breast cancer and metastatic stomach cancer.
Further, Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US.
As per Biocon, “Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licences 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.”
