The Devil is in the Details: Health Care Reform, Biosimilars, and Implementation Challenges for the Food and Drug Administration
Seton Hall University - School of Law
June 27, 2011
Jurimetrics Journal, Vol. 51, pp. 279–292, 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.
Number of Pages in PDF File: 14
Keywords: Biologics, Food and Drug Administration, biosimilars, Patient Protection and Affordable Care ActAccepted Paper Series
Date posted: May 26, 2011 ; Last revised: June 28, 2011
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