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The Regulation of Biologics and Biosimilars: An Introduction

Understand differences between biologics and small molecule drugs and effect on regulating generic drugs and biosimilars. Learn regulatory standards for biosimilars and interchangeable biosimilars. Discuss the regulatory exclusivities available for biologics. Address the differences between switching and substitution. Explore the Patent Dance.

Kelly Cho, Senior Managing Associate, Sidley Austin LLP

This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in April 2025.

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