What Is the BPCIA?

BPCIA

Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) to provide an abbreviated pathway for biosimilars to gain FDA approval through submission of an abbreviated Biologics License Application (aBLA).

At a high level, the BPCIA includes two main statutory provisions: 42 U.S.C. § 262(k) relates to the regulatory aspects of the Act, while 42 U.S.C. § 262(l) outlines a framework for the applicant and reference product sponsor to resolve patent disputes.