FDA Regulation of Biosimilars

FDA in the Twenty First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press 2015)

Posted: 17 Sep 2015

See all articles by Erika Lietzan

Erika Lietzan

University of Missouri School of Law

Henry G. Grabowski

Duke University - Department of Economics

Date Written: September 16, 2015

Abstract

The Biologics Price Competition and Innovation Act (BPCIA) was enacted in March 2010 as part of the Affordable Care Act (ACA). The objective of the BPCIA, like the Hatch-Waxman Amendments of 1984 for generic copies of non-biological drugs, was to increase price competition and generate cost savings by authorizing approval of follow-on products that rely on pioneer research while at the same time maintaining incentives for innovation.

This essay, in the just-released "FDA in the 21st Century" (Columbia University Press), explores the new biosimilar licensure scheme. Among other things, it concludes that obtaining licensure for a biosimilar biological product will require a significantly greater investment of time and resources than is required for obtaining approval of a generic drug, and that this – when combined with the fact that biosimilars will not automatically be deemed interchangeable – is likely to mean there will be fewer biosimilar market entrants per biological product than there are generic market entrants per drug. It also means that for the foreseeable future, the biosimilar marketplace is more likely to resemble the brand-to-brand competitive marketplace than the generic drug marketplace. The essay also discusses the impact of possible scientific advances (including the ability to demonstrate “fingerprint-like” similarity of biosimilars and their reference products) on cost savings, competition, and innovation, and it addresses several key open issues (such as nonproprietary names for biosimilars, and the issue whether and to what extent FDA will permit extrapolation of effectiveness from one indication to another) the resolution of which could similarly have a profound impact on cost savings, the nature of competition in the market, and incentives to innovate.

Note: The essay is unfortunately not available for download, but it can be found at Chapter 22 of FDA in the Twenty First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press 2015).

Keywords: biosimilars, generic drugs, BPCIA, Hatch-Waxman, price competition, innovation, cost savings, pharmaceuticals, biotechnology

Suggested Citation

Lietzan, Erika and Grabowski, Henry G., FDA Regulation of Biosimilars (September 16, 2015). FDA in the Twenty First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press 2015). Available at SSRN: https://ssrn.com/abstract=2661677

Erika Lietzan (Contact Author)

University of Missouri School of Law ( email )

Missouri Avenue & Conley Avenue
Columbia, MO MO 65211
United States

Henry G. Grabowski

Duke University - Department of Economics ( email )

213 Social Sciences Building
Box 90097
Durham, NC 27708-0204
United States
919-660-1839 (Phone)

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