Abstract

http://ssrn.com/abstract=1852503
 
 

Footnotes (52)



 


 



Follow-On Biologics: Implementation Challenges and Opportunities


Jordan Paradise


Seton Hall University - School of Law

April 26, 2011

Seton Hall Law Review, Vol. 41, p. 501, 2011

Abstract:     
The March 23, 2010, enactment of the Patient Protection and Affordable Care Act (PPACA) and the companion Health Care and Education Affordability Reconciliation Act of 2010 ushered in landmark reform of the American health care system. Along with sweeping overhauls of the health care system generally, PPACA also provides a new regulatory challenge for the Food and Drug Administration (FDA). A subtitle within PPACA, the Biologics Price Competition and Innovation Act (BPCIA), bestows upon FDA broad authority to implement an abbreviated approval route to market for biological products (also known as biologics) that are “biosimilar” to an existing marketed product. This brief article will provide a basic comparison of biologics and conventional pharmaceutical drugs that will prove central to the FDA’s development of this follow-on biologic pathway as well as specifically examine the content and scope of the BPCIA provisions and identify future challenges for the FDA. It will conclude by highlighting details of presentations during the roundtable held at the Seton Hall University School of Law and introduce the two resulting articles contained within Volume 41 of the Seton Hall Law Review.

Number of Pages in PDF File: 10

Keywords: Biologics, FDA, Biologics Price Competition and Affordable Care Act

Accepted Paper Series


Download This Paper

Date posted: May 26, 2011  

Suggested Citation

Paradise, Jordan, Follow-On Biologics: Implementation Challenges and Opportunities (April 26, 2011). Seton Hall Law Review, Vol. 41, p. 501, 2011. Available at SSRN: http://ssrn.com/abstract=1852503

Contact Information

Jordan K. Paradise (Contact Author)
Seton Hall University - School of Law ( email )
One Newark Center
Newark, NJ 07102-5210
United States
Feedback to SSRN


Paper statistics
Abstract Views: 481
Downloads: 85
Download Rank: 168,100
Footnotes:  52

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo6 in 0.297 seconds