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. Visit our website – www.RegProject.org – to learn more, view all of our content, and connect with us on social media.*******As always, the Federalist Society takes no position on particular legal or public policy issues; all expressions of opinion are those of the speaker.

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