Mylan’s biosimilar version of the breast cancer drug, Herceptin, may soon be available, thanks to a settlement reached between the pharmaceutical company and the makers of the reference biologic, Genentech and Roche. The global license will allow Mylan to market its trastuzumab product in multiple countries around the world, excluding Brazil, Mexico and Japan.
A condition of the agreement required Mylan to drop two patent litigation cases against Genentech, regarding Herceptin. Mylan has already submitted an application for the Herceptin biosimilar to the US Food and Drug Administration (FDA), and the company hopes to be the first to introduce the trastuzumab drug to the US market.
“There is an unmet need for access to more affordable versions of biologic products such as trastuzumab,” said Heather Bresch, CEO of Mylan. “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.”
Mylan is developing trastuzumab alongside Biocon, along with five other biologic products. While Mylan has sole commercialization rights for the biosimilar in the US, Canada, Japan, Australia, New Zealand and in the European Union, Biocon will work alongside Mylan to commercialize the cancer treatment in the rest of the world.
Mylan is also awaiting European Medicines Agency (EMA) approval for trastuzumab. Currently, the biosimilar is sold in 14 emerging markets around the world.
“With 16 biosimilar products in development,” said Bresch, “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.”
In 2016, sales of Herceptin reached nearly $4.5 billion in the US and European markets. In addition to its pending regulatory submission for trastuzumab, Mylan and Biocon have also applied for approval for their biosimilar of Amgen’s Neulasta.