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Mylan Clears Runway For US Herceptin Biosimilar Launch

 
• By Jessica Merrill

The generic drug manufacturer is poised to be first to market with a biosimilar version of Roche’s blockbuster breast cancer therapy after reaching a license agreement. The date of a potential launch remains confidential.

airport runway under the sun as background

Mylan NV could be the first manufacturer to launch a biosimilar version of Roche’s blockbuster breast cancer treatment Herceptin (trastuzumab) in the US. The company has an application for a version of trastuzumab pending at FDA with a user fee date of Sept. 3., and now the company has also cleared the crucial intellectual property hurdle.

Mylan announced March 13 that it has reached a patent settlement agreement and a licensing deal with Roche related to patents for Herceptin. The global license will provide a clear path for Mylan to commercialize trastuzumab globally (excluding Japan, Brazil and Mexico), the firm said. The catch is that the US launch timeline remains unknown

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