IP Explained: Why IP protections are important for biologic medicines

Biologics are cutting-edge therapies that treat or cure some of the most challenging and costly diseases. These medicines are created from living organisms through highly complex manufacturing processes and include gene and cell therapies, therapeutic proteins, monoclonal antibodies and vaccines. In 2010, theBiologics Price Competition and Innovation Act (BPCIA) created an abbreviated regulatory approval pathway for biosimilars – a product that is “similar” to a biologic medicine that was already licensed by the U.S. Food and Drug Administration (FDA). Until Congress passed the BPCIA, there was no pathway to bring biosimilars to market. As of July 2019,21 biosimilars have been approved in the U.S.
Source: The Catalyst - Category: Pharmaceuticals Authors: Tags: Research and Development Intellectual Property Biologics and Biosimilars IP Explained Source Type: news