Explainer Episode 53 – Biologics, Biosimilars, and the Two-fold U.S. Approval Framework’s Possible Impact on Prices

Biosimilars, a category of biologic (medicine derived from a living organism), require approval, at least in the U.S. by the Food and Drug Administration (FDA). There are two types of approval the FDA can give a biosimilar: “approved” and “interchangeable.” This distinction, unique to the U.S. system, along with the burden of proof required by the FDA, can cause confusion and create challenges for manufacturers seeking to get a biosimilar licensed.

In this podcast Dr. Roger Klein (M.D. J.D.) joins us to provide an introduction to biologics & biosimilars: what they are, how they are regulated/ approved in the United States, and what the effects of our current regulatory system can be for the approval of biosimilars.

Roger D. Klein

Faculty Fellow, Center for Law, Science & Innovation

Sandra Day O'Connor College of Law

FDA & Health
Regulatory Process

The Federalist Society and Regulatory Transparency Project take no position on particular legal or public policy matters. All expressions of opinion are those of the speaker(s). To join the debate, please email us at [email protected].

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