New Delhi: The U.S. Food and Drug Administration (FDA) has approved Mylan´s Ogivri (trastuzumabdkst), a biosimilar to Herceptin (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 CEO Heather Bresch commented: “The approval of OgivriTM represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system. It will allow us to bring this important biosimilar the first of its kind to market in the U.S., expanding cancerpatient access to more affordable treatment. As one of the nation´s leading suppliers of cancer medicines, Mylan is excited to add to our portfolio a product representing a new generation of targeted therapies that have radically changed the way the disease is treated. OgivriTM is one of many biosimilars in our robust pipeline that we look forward to introducing in the coming years as part of our ongoing commitment to increasing access to important medicines for patients.”
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.