On February 9, 2012, the U.S. Food and Drug Administration (FDA) issued three draft guidance documents– the first since the Biologics Price Competition and Innovation Act passed in March 2010 – for the development of biosimilars. The biosimilars market is expected to reach $8 billion by 2020. The three guidance documents are:
Maximizing the protection and value of intellectual property assets is often the cornerstone of a business's success and even survival. In this blog, Nutter's Intellectual Property attorneys provide news updates and practical tips in patent portfolio development, IP litigation, trademarks, copyrights, trade secrets and licensing.