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
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
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
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.
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.