With the license, Mylan now has access to the commercialization of trastuzumab in markets across the globe. The agreement eliminates legal uncertainty surrounding Mylan’s product, while further eliminating patent litigation expenses with Genentech and Roche.
"There is an unmet need for access to more affordable versions of biologic products such as trastuzumab,” Mylan CEO Heather Bresch said in a statement. “We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the U.S. and around the world."
Mylan has one of the industry's broadest portfolios with 16 biosimilar products in development.
"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," Bresch said.