FDA approves first Herceptin biosimilar from Mylan, Biocon

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FDA approves first Herceptin biosimilar from Mylan, Biocon

By David Salazar - 12/01/2017

The Food and Drug Administration has approved the first biosmilar to treat HER2-positive breast cancer and certain gastric cancers, the agency announced Friday. Ogivri (trastuzumab-dkst), from Pittsburgh-based Mylan and Bengaluru, India-based Biocon, is a biosimilar of Genentech’s Herceptin, and the second biosimilar approved to treat cancer.


“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs,” FDA commissioner Scott Gottlieb said. “This is especially important when it comes to diseases like cancer, that have a high cost burden for patients. We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”


The product is the first biosimilar approved under Mylan’s and Biocon’s joint portfolio in the United States, the companies said. The companies said Mylan expects to potentially be the first company to offer a Herceptin biosimilar, and that the approval clears a path for the company to commercialize the biosimilar in various global markets.


“The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system,” Mylan CEO Heather Bresch said. “Ogivri 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.”


Biocon chief medical director Kiran Mazumdar said, “The U.S. FDA's approval for our biosimilar trastuzumab is indeed a crowning moment that puts us in an exclusive league of global biosimilar players. It strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world. It is an important milestone in our journey of developing advanced therapies that have the potential to benefit billions of patients.”