Mylan Reaches Global Settlement to Commercialize Biosimilar

Mylan NV reached a global settlement with Genentech and Hoffmann-La Roche regarding patents for trastuzumab (Herceptin).

The settlement will provide Mylan with global licenses for its trastuzumab product to commercialize the drug in various markets worldwide, according to a press release. The licenses pertain to all countries except Brazil, Mexico, and Japan.

Trastuzumab is a monoclonal antibody approved for the treatment of metastatic breast cancer and early-stage breast cancer that is human epidermal growth factor receptor 2-positive and has or has not spread to the lymph nodes.

In addition to the settlement eliminating any legal uncertainty over the launch of trastuzumab, it will also eliminate further patent litigation expenses associated with Genentech and Roche.

As part of the settlement, Mylan has agreed to withdraw its pending Inter Partes Review challenges against 2 Genentech patents in the United States.

The FDA recently accepted Mylan’s Biologics License Application for the proposed biosimilar trastuzumab, which is currently under review. The anticipated FDA goal date is September 3, 2017, according to the release.

Mylan anticipates it could potentially be the first drug manufacturer to launch a biosimilar to trastuzumab in the United States.

“There is an unmet need for access to more affordable versions of biologic products such as trastuzumab,” Heather Bresch, CEO of Mylan, said in a release. “We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the US and around the world. With 16 biosimilar products in development, we believe Mylan has one of the industry’s broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialize these products on a global basis.”

All other terms and conditions of the settlement and license agreement are confidential.