Mylan has agreed a global settlement with Genentech and Roche over patents for the blockbuster cancer drug Herceptin® (trastuzumab). The terms provide Mylan with global licenses for its biosimilar trastuzumab product.
The global license will allow Mylan to commercialise its trastuzumab product in markets around the world. The licenses apply to all countries except Japan, Brazil and Mexico. The settlement also eliminates further patent litigation expenses associated with Genentech and Roche.
In return, Mylan has agreed to withdraw its pending Inter Partes Review challenges against two U.S. 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 U.S. Food and Drug Administration, Mylan could be the first company to launch a biosimilar to Herceptin in the U.S..
Mylan CEO Heather Bresch said: "There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. 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."
Mylan has exclusive commercialisation rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries while Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.