FDLI

About This Monograph

Prior to 2012, FDLI published the FDLI Monograph Series, which consisted of six monographs annually. We now publish 4 to 6 Primers each year.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA), which created a pathway for approval of biosimilar and interchangeable biological products, became law on March 23, 2010. The statute does not require the Food and Drug Administration (FDA) to issue implementing regulations or guidance, although the agency will almost certainly eventually issue both. To date, however, FDA and agency officials have said very little publicly about their interpretation of the statute. In October 2010, the agency opened a public docket for comment, listing nearly two dozen questions on which it sought input. In November, the agency held a two-day public hearing under part 15 of its regulations, asking witnesses many of the same questions but also raising new issues for consideration. These docket and hearing questions constitute most of what we know about the agency's thinking on the statute.

This monograph is intended to provide lawyers practicing in this area with a tool for planning in the absence of clear guidance from FDA. It describes the positions taken by FDA with respect to approval and regulation of biosimilars during the multi-year stakeholder process that eventually led to enactment of the legislation. It describes the provisions of the statute. It identifies and explains the issues and questions raised by FDA to date and places them, where possible, within the context of prior agency statements. It then summarizes the positions taken by stakeholders in November and December on those issues and questions.

After reading this Monograph, you will be better able to:

1. Understand how and why statements FDA has made over the years about proteins approved under the Federal Food, Drug, and Cosmetic Act (FDCA) may shed light on its implementation of the BPCIA.
2. Understand the differences between, and relevance of, Dr. Woodcock's 2007 article in Nature Reviews Drug Discovery, Secretary Leavitt's 2007 letter to the Senate, and Dr. Torti's 2008 letter to the House, on biosimilar issues.
3. Understand the positions taken by stakeholders on the new definition of "biological product" and on the appropriate scope of the pathway at this point in time.
4. Understand the debate over the use of data from clinical trials involving comparisons with innovative biological products not approved by FDA.
5. Understand the positions urged on FDA with respect to interpretation of the "first licensure" provision (relating to exclusivity), including possible meanings of the phrase "related entity."
6. Understand the discussion in the FDA docket over the current capabilities of analytical technology to demonstrate structural similarity of biological products.
7. Appreciate the positions taken by stakeholders on the role of clinical pharmacokinetic and pharmacodynamic studies and whether, and when, studies with efficacy (clinical) outcomes are necessary.
8. Understand the legal and regulatory structure that frames the issue of nonproprietary names for biological products, FDA's prior statements on naming, and the positions taken by stakeholders on this contentious issue.
9. Appreciate the relevance of the history of therapeutic equivalence ratings at FDA and understand the many issues FDA faces in implementing the interchangeability provisions of the BPCIA.
10. Understand the key differences between the patent litigation process under BPCIA and the patent litigation process under the Hatch-Waxman Amendments.
11. Understand the role that some stakeholders believe FDA should play in implementation of the patent provisions of the BPCIA.