The Future Of Biosimilars In Health Care And Litigation

Law360, New York (June 24, 2010, 3:55 PM EDT) -- The Biologics Price Competition and Innovation Act of 2009 became law as Title VII of the recently passed Patient Protection and Affordable Care Act (Pub. Law. No. 111-148).

The Biosimilars Act creates the first U.S. pathway for the commercialization of follow-on biologics (“biosimilars”), guarantees 12 years of marketing exclusivity for innovator biopharmaceutical products following approval from the U.S. Food and Drug Administration, and provides regulations regarding patent listings and alleged patent infringement actions.

While the Biosimilars Act provides detail on the much-debated regulatory issues, legal practitioners...
To view the full article, register now.