Mylan NV has agreed to the terms of a global settlement with Genentech Inc and F. Hoffmann-La Roche Ltd in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product.
The global license will provide a clear pathway for Mylan to commercialise its trastuzumab 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 Genentech and Roche.
Mylan has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US Genentech patents as part of the settlement.
Following this settlement and the recent acceptance of Mylan's application for its proposed biosimilar trastuzumab with the US Food and Drug Administration (FDA), Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin 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 trastuzumab. 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 Mylan 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 trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialisation rights for the proposed biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand 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.
In the US, Mylan’s Biologics License Application (BLA) for proposed biosimilar trastuzumab is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is September 3, 2017.
Mylan currently markets its trastuzumab products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the US.
