Mylan Obtains Global License to Trastuzumab in IPR Settlement

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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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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