US FDA Approves Herceptin for Cancer Drug Treatment

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

Ogivri is the first United States Food and Drug Administration (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.

The company to offer a Mylan and Biocon’s biosimilar potentially anticipates to Herceptin because of its ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year, it included.

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

For cancer drugs, as one of the countries is leading suppliers, Mylan is eager to add to its portfolio a product representing a new generation of targeted treatments that have profoundly changed the way the disease is treated, she included.

Biocon CMD Kiran Mazumdar-Shaw said, “Biocon and Mylan have a shared commitment to improve access to cutting-edge bio-therapeutics and this approval will allow us to give an affordable alternative for cancer care that will address the unmet needs of patients in the US”.

Mylan and Biocon’s biosimilar of cancer drug Herceptin is also under review by regulatory authorities in Europe, Canada, Australia and several additional markets, the statement said.

It is currently approved in 19 nations around the globe, including India, consequently providing increased access to this more affordable biologic for cancer patients, it included.

Mylan and Biocon are exclusive partners on an expansive 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 worldwide commercial center, the statement said.

While for the product Mylan has commercialization rights in Australia, Canada, New Zealand, US, Japan and in the European Union and European Free Trade Association nations.

Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world, it included.


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