The Patient Protection and Affordable Care Act, which included the Biologics Price Competition and Innovation Act of 2009, created a regulatory approval pathway for “biosimilars,” biological products shown to be biosimilar to a licensed reference product. Notably, the Act also established a 12-year market exclusivity period for the licensed reference product, as well as procedures for resolving patent disputes based on a biosimilar application. With the release of FDA draft guidance on February 9, 2012, active discussion on many issues related to execution and operations have surfaced as new regulations and procedures are put into action.
Our Life Sciences Industry Team is committed to working with you as you confront issues related to the Act. Our team comprises experienced biotechnology attorneys in the areas of IP and IP litigation, FDA regulatory, and corporate law, all with an understanding of the complex legal and business issues surrounding biosimilars and how they impact your life sciences enterprise.