Biosimilar Law and Regulation: An Essential Guide
FDLI Monograph Series, Volume 2, Number 5, June 2011
228 Pages Posted: 20 Feb 2013
Date Written: 2011
This monograph provides a primer on key legal, scientific, regulatory, and policy issues faced by FDA and stakeholders as the agency implements the Biologics Price Competition and Innovation Act of 2009. It provides historical background on federal regulation of biological drugs since 1902 and a history of FDA's views and positions on biosimilars including during the legislative process from 2006 to 2010. In addition to discussing the regulatory and patent provisions of the law, it delves into the questions raised by FDA and the positions that had been taken by stakeholders to date. The author does not, in this monograph, take a position on any of the issues in question.
Keywords: biosimilars, BPCIA, FDA, biologics
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