63 Pages Posted: 6 Oct 2016 Last revised: 25 Oct 2016
Date Written: October 5, 2016
Six years ago, Congress fundamentally changed how federal law encourages the discovery and development of certain new medicines and for the first time authorized less expensive “duplicates” of these medicines to be approved and compete in the marketplace. The medicines at issue are biological medicines, generally made from, or grown in, living systems. Many of the world’s most important and most expensive medicines for serious and life–threatening diseases are biological medicines.
We have a profound interest in understanding and evaluating the impact of this legislation on innovation and competition. Scholars and courts considering this question may be tempted to reason from, or analogize to, experience with generic drugs. And the 2010 biosimilar law was similar to the 1984 generic drug statute in basic purpose and structure. But the biologic framework as a whole — the complete landscape within which innovation and competition in biological medicines take place — is profoundly different from anything that scholars and courts have seen before.
This Article is the first to offer a high level description of the framework organized around the characteristics that define it and distinguish it from the conventional drug framework. It argues that unlike the drug framework, the framework for competition and innovation in biologics is variable and dynamic. And it argues that biologic framework separates and distinguishes patents, both conceptually and functionally, from the regulatory paradigm. As a result, although scholars and policymakers focusing on innovation incentives and competitive behavior with respect to medicines have decades of experience with the generic drug paradigm, there is a meaningful risk that this experience is mostly irrelevant when it comes to biologics. This article provides the basis for understanding both the specific differences and broader thematic divergence at play in the biologic paradigm.
Keywords: Generic Drugs, Biosimilars, Patents, Antitrust, Coverage, Reimbursement, Substitution, Marketplace Dynamics, Competition, Medicare, Medicaid
Suggested Citation: Suggested Citation
Lietzan, Erika Fisher, The Uncharted Waters of Competition and Innovation in Biological Medicines (October 5, 2016). Florida State University Law Review, Vol 44, 2017, Forthcoming; University of Missouri School of Law Legal Studies Research Paper No. 2016-27. Available at SSRN: https://ssrn.com/abstract=2848606