On Monday, Mylan announced that it has a deal of agreement of being in terms of a global settlement with F. Hoffman-La Roche Ltd. and Genentech, Inc., which will give a clear path for Mylan to release its version of Herceptin, a drug to treat breast cancer. This deal renders Mylan with global licenses for its trastuzumab product.
Financial conditions of the deal between Mylan (Nasdaq: MYL) and Genentech and F. Hoffmann-La Roche were not announced, even though Mylan will get a global license to launch trastuzumab that is a generic name for Herceptin. The License pertains to all countries except Brazil, Japan, and Mexico. The deal will also eliminate and take back challenges to patents by Genentech.
As a part of the settlement, Mylan has agreed to withdraw the pending Inter Partes Review (IPR) challenges against two U.S. Genentech patents.The company also claimed that they might be the first one in the United States to launch a biosimilar product for Herceptin; and also its application has been received by the Food and Drug Administration.
Several other terms and conditions of the deal settlement and license agreement are confidential.
In a statement on Monday, Heather Bresch, Mylan’s CEO said, "There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. 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. 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."
Biosimilars are drugs which are alike the FDA approved already existing product which comprises of little or no changes in safety and efficiency, as per the FDA. Companies like Biocon Ltd. and Mylan, both had applied for license for trastuzumab back in November 2016.
The projected biosimilar trastuzumab by Mylan, is one of the six biological products that has been co-developed by Biocoan and Mylan for the marketplace globally.
The company has private commercialization rights for the projected product in Australia, Canada, U.S., New Zealand, japan, and in the European Free Trade association countries and European Union. Biocon has co-private commercialization rights along with Mylan for the product in the rest of the world.
In the United States, Biologics License Application (BLA) of Mylan, for the projected products is presently under the review scanner by the FDA. The predicted FDA objective date fixed under the Biosimilar User Fee Act (BsUFA) is 3rd September 2017.
Mylan presently manufactures its trastuzumab products in 14 emerging markets and has pending submissions especially in the European Union and many other emerging markets, along with the United States.