The US Food and Drug Administration (USFDA) has approved biosimilar Ogivri, co-developed by Mylan NV and Biocon, for the treatment of certain breast and stomach cancer.
Ogivri is the first USFDA approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US, the two companies said in a joint statement.
Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of its ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year, it added.
Mylan CEO Heather Bresch said: “The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the US healthcare system.”
As one of the nation s leading suppliers of cancer medicines, Mylan is excited to add to its portfolio a product representing a new generation of targeted therapies that have radically changed the way the disease is treated, she added.
“Biocon and Mylan have a shared commitment to enhance access to cutting-edge bio-therapeutics and this approval will enable us to provide an affordable alternative for cancer care that will address the unmet needs of patients in the US,” Biocon CMD Kiran Mazumdar-Shaw said.
Mylan and Biocon’s biosimilar for Herceptin is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets, the statement said.
It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients, it added.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Biosimilar for Herceptin is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the statement said.
While Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.
Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world, it added.