You are here: Home » Companies » News
Business Standard

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

Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin

Press Trust of India  |  New Dehi 


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.

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 nations leading suppliers of 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.

"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 care that will address the unmet needs of patients in the US," CMD Kiran Mazumdar-Shaw said.

Mylan 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.

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

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

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First Published: Sat, December 02 2017. 13:19 IST