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, notes a posting on the website of Pharmaceutical Research and Manufacturers of America by Tom Wilbur, a director of public affairs at PhRMA.

In 2010, the Biologics 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 US Food and Drug Administration. 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 USA.

In this IP Explained post, Mr Wilbur explores the balance struck by the BPCIA to provide intellectual property protections for innovator biologics while encouraging competition in the marketplace.