The Devil is in the Details: Health Care Reform, Biosimilars, and Implementation Challenges for the Food and Drug Administration

Abstract:     
The Biologics Price Competition and Innovation Act (BPCIA), part of the Patient Protection and Affordable Care Act (PPACA), placed a major regulatory challenge in front of the Food and Drug Administration (FDA). The BPCIA grants broad authority to the FDA to develop and implement a market approval pathway for “biosimilar” and “interchangeable” biological products. This article provides an over-view of the nature and regulation of biological products as compared to conventional small molecule drugs; surveys the content and scope of the BPCIA provisions, high-lighting core definitions, requirements for submissions to the FDA, and the basics of the intricate patent disclosure and resolution process; provides an overview of the FDA’s actions to date in the implementation of the biosimilar pathway; and identifies several challenges facing the FDA and various stakeholders.

Number of Pages in PDF File: 14

Keywords: Biologics, Food and Drug Administration, biosimilars, Patient Protection and Affordable Care Act

Accepted Paper Series