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Mylan inks settlement pact with Genentech & Roche on cancer drug Herceptin

Trastuzumab (Herceptin) is one of the 6 biologic products co-developed by Mylan & Biocon

BS B2B Bureau  |  Pittsburgh, USA 

NV has agreed to the terms of a global settlement with Inc and F. Hoffmann-La Ltd in relation to patents for (trastuzumab), which provides with global licenses for its product.

The global license will provide a clear pathway for to commercialise its product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico. In addition to eliminating any legal uncertainty over the launch of Mylan's trastuzumab, the settlement eliminates further patent litigation expenses associated with and

has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US patents as part of the settlement.

Following this settlement and the recent acceptance of Mylan's application for its proposed biosimilar with the US Food and Drug Administration (FDA), anticipates potentially being the first company to launch a biosimilar to in the US. All other terms and conditions of the settlement and license agreement are confidential. 

Heather Bresch, CEO, Mylan, commented, “There is an unmet need for access to more affordable versions of biologic products such as We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the US and around the world. With 16 biosimilar products in development, we believe has one of the industry's broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialise these products on a global basis.”

Mylan's proposed biosimilar is one of the six biologic products co-developed by and for the global marketplace. has exclusive commercialisation rights for the proposed biosimilar in the US, Canada, Japan, Australia, New Zealand 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.

In the US, Mylan’s Biologics License Application (BLA) for proposed biosimilar is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is September 3, 2017.

currently markets its products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the US.

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Mylan inks settlement pact with Genentech & Roche on cancer drug Herceptin

Trastuzumab (Herceptin) is one of the 6 biologic products co-developed by Mylan & Biocon

Trastuzumab (Herceptin) is one of the 6 biologic products co-developed by Mylan & Biocon
NV has agreed to the terms of a global settlement with Inc and F. Hoffmann-La Ltd in relation to patents for (trastuzumab), which provides with global licenses for its product.

The global license will provide a clear pathway for to commercialise its product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico. In addition to eliminating any legal uncertainty over the launch of Mylan's trastuzumab, the settlement eliminates further patent litigation expenses associated with and

has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US patents as part of the settlement.

Following this settlement and the recent acceptance of Mylan's application for its proposed biosimilar with the US Food and Drug Administration (FDA), anticipates potentially being the first company to launch a biosimilar to in the US. All other terms and conditions of the settlement and license agreement are confidential. 

Heather Bresch, CEO, Mylan, commented, “There is an unmet need for access to more affordable versions of biologic products such as We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the US and around the world. With 16 biosimilar products in development, we believe has one of the industry's broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialise these products on a global basis.”

Mylan's proposed biosimilar is one of the six biologic products co-developed by and for the global marketplace. has exclusive commercialisation rights for the proposed biosimilar in the US, Canada, Japan, Australia, New Zealand 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.

In the US, Mylan’s Biologics License Application (BLA) for proposed biosimilar is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is September 3, 2017.

currently markets its products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the US.

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Business Standard
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Mylan inks settlement pact with Genentech & Roche on cancer drug Herceptin

Trastuzumab (Herceptin) is one of the 6 biologic products co-developed by Mylan & Biocon

NV has agreed to the terms of a global settlement with Inc and F. Hoffmann-La Ltd in relation to patents for (trastuzumab), which provides with global licenses for its product.

The global license will provide a clear pathway for to commercialise its product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico. In addition to eliminating any legal uncertainty over the launch of Mylan's trastuzumab, the settlement eliminates further patent litigation expenses associated with and

has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US patents as part of the settlement.

Following this settlement and the recent acceptance of Mylan's application for its proposed biosimilar with the US Food and Drug Administration (FDA), anticipates potentially being the first company to launch a biosimilar to in the US. All other terms and conditions of the settlement and license agreement are confidential. 

Heather Bresch, CEO, Mylan, commented, “There is an unmet need for access to more affordable versions of biologic products such as We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the US and around the world. With 16 biosimilar products in development, we believe has one of the industry's broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialise these products on a global basis.”

Mylan's proposed biosimilar is one of the six biologic products co-developed by and for the global marketplace. has exclusive commercialisation rights for the proposed biosimilar in the US, Canada, Japan, Australia, New Zealand 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.

In the US, Mylan’s Biologics License Application (BLA) for proposed biosimilar is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is September 3, 2017.

currently markets its products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the US.

image
Business Standard
177 22