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FDA Okays First Biosimilar For Treatment Of Certain Breast And Stomach Cancers

Mylan N.V. (MYL) and Biocon Ltd. said that the U.S. Food and Drug Administration has approved Mylan's Ogivri or trastuzumab-dkst, a biosimilar to Herceptin or trastuzumab, 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 (gastric or gastroesophageal junction adenocarcinoma).

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.

Mylan and Biocon's biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients.

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