Document Type


Publication Date



On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from September 2006 to enactment, and section IV discusses the BPCIA in some detail. These sections show, and the conclusion in section V explains, that the regulatory and intellectual property issues addressed in the final 2010 legislation were debated, discussed, explored, and vetted by stakeholders — including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), Democrats and Republicans in both House and Senate, the United States Pharmacopoeia, the generic industry, the biosimilar industry, trade associations, professional organizations like the Drug Information Association (DIA), and European regulators — for (in some cases) as many as ten years. Moreover, as these sections also show, like the Hatch-Waxman amendments of 1984, the final legislation represents a true compromise of competing interests.


Originally published in Food and Drug Law Journal.



To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.