Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As part of the settlement, Mylan agreed to withdraw its IPR challenges to U.S. Pat. Nos. 6,407,213 and 6,331,415.
The license pertains to commercialization rights in all countries except Japan, Brazil, and Mexico. In the U.S., Mylan’s aBLA for a trastuzumab biosimilar is currently under review by the FDA; with this settlement, Mylan anticipates being the first company to launch a biosimilar to Herceptin® in the U.S. No launch date was disclosed.