The Biologic and Biosimilar Price Competition and Innovation Act (BPCIA)

The Biologics and Biosimilar Price Competition and Innovation Act (BPCIA) is a U.S. law that allows for the approval of biosimilars—products similar to already approved biologic drugs. It aims to promote competition in the biologic drug market, which can lead to lower prices for patients. The BPCIA establishes a regulatory pathway for manufacturers to demonstrate that their biosimilar is safe and effective, facilitating easier access to these treatments while encouraging innovation in the biotechnology field. This act is essential for expanding patient options and increasing affordability in healthcare.