The Devil is in the Details: Health Care Reform, Biosimilars, and Implementation Challenges for the Food and Drug Administration
14 Pages Posted: 26 May 2011 Last revised: 28 Jul 2013
Date Written: June 27, 2011
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.
Keywords: Biologics, Food and Drug Administration, biosimilars, Patient Protection and Affordable Care Act
Suggested Citation: Suggested Citation