The U.S. Market for Biosimilars and Biologics Medicines

Teaser image of PhRMA's new Biologics and Biosimilars overview fact sheet

Since Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biosimilars have become an important way to bolster competition and increase options for patients. The BPCIA created an abbreviated approval pathway for biosimilars while providing 12 years of data protection following the first licensure of innovative biologics, balancing the goal of reducing costs with the need to maintain incentives for the development of new innovative biologics. Since enactment of the BPCIA, a robust biosimilars market has emerged in the U.S., yielding increased competition and substantial savings for patients and the government.

Teaser image of PhRMA's new Biologics and Biosimilars overview fact sheet