Mylan, Biocon's biosimilar of cancer drug Herceptin gets USFDA nod

Biotechnology major has said the US health regulator has approved NV's biosimilar Ogivri, co-developed with it, for the treatment of certain breast and stomach cancers.

Ogivri is the first United States Food and Drug Administration (USFDA) approved biosimilar to and the first biosimilar from and Biocons joint portfolio approved in the US, the two said in a joint statement.

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.

CEO Heather Bresch said: "The approval of Ogivri represents a monumental achievement for to increase patient access to biosimilars and deliver significant savings to the US healthcare system."

As one of the nations leading suppliers of medicines, 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.

"and have a shared commitment to enhance access to cutting-edge bio-therapeutics and this approval will enable us to provide an affordable alternative for care that will address the unmet needs of patients in the US," CMD Kiran Mazumdar-Shaw said.

and Biocon's biosimilar for 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 patients, it added.

and are exclusive partners on a broad portfolio of biosimilar and insulin products. Biosimilar for is one of the six biologic products co-developed by and for the global marketplace, the statement said.

While has exclusive commercialisation rights for the product in the US, Canada, Japan, Australia, and in the European Union and European Free Trade Association countries. has co-exclusive commercialisation rights with for the product in the rest of the world, it added.



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