Mylan has agreed to the terms of a global settlement with Roche and its subsidiary, Genentech, in relation to patents for Herceptin (trastuzumab), one of Roche’s top-selling cancer drugs with 2016 sales of CHF 6.78 billion ($6.73 billion). The settlement provides Mylan with global licenses for its biosimilar trastuzumab product.
Mylan has been developing a biosimilar to Roche’s Herceptin with its partner, Bicon, a Bangalore, India-based biopharmaceutical company, for which the partners submitted a biologics license application with the US Food and Drug Administration in November 2016, with an anticipated goal date set on Sept. 3, 2017 under the Biosimilar User Fee Act. Roche’s Herceptin is indicated for treating HER2-positive breast and gastric cancers.
As part of the global settlement, Mylan has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US Genentech patents: Patent Numbers 6,407,213 on the method for making humanized antibodies and 6,331,415 on methods for producing immunoglobulins, vectors, and transformed host cells. In addition to eliminating any legal uncertainty over the launch of Mylan's biosimilar trastuzumab, the settlement eliminates further patent litigation expenses associated with Genentech and Roche. All other terms and conditions of the settlement and license agreement were not disclosed.
The global license will provide Mylan a pathway to commercialize its biosimilar trastuzumab in various markets worldwide on the dates that the licenses becomes effective, which were not disclosed. The licenses pertain to all countries except Japan, Brazil, and Mexico.
Mylan's proposed biosimilar trastuzumab is one of six biologic products co-developed by Mylan and Biocon. Mylan has exclusive commercialization rights for the 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 commercialization rights with Mylan for the product in the rest of the world. Mylan currently markets its biosimilar trastuzumab products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the US