Mylan in deal to market biosimilar Herceptin

13 March 2017

Netherlands-incorporated generic drugmaker Mylan (Nasdaq: MYL) has agreed to the terms of a global settlement with Genentech and its Swiss parent Roche (ROG: SIX) to market a biosimilar of their mega-blockbuster cancer drug.

The global license will provide a clear pathway for Mylan to commercialize its Herceptin (trastuzumab) biosimilar in various markets around the world, commencing on the license effective dates, though the companies are keeping these dates confidential. The drug generated sales of $6.7 billion for Roche last year.

The license is for 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 and Roche. Mylan has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US Genentech patents (patent numbers 6,407,213 and 6,331,415) as part of the settlement.

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