The Regulation of Biologics and Biosimilars: An Introduction
A session from FDLI’s Introduction to Drug Law and Regulation
Recorded April 22-23, 2025
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.
KELLY J.Y. CHO is an associate in the Food, Drug and Medical Device Regulatory group of Sidley Austin LLP in Washington DC. She advises clients on a wide range of FDA regulatory and compliance matters affecting pharmaceuticals, biological products, medical devices, food and dietary supplements. Ms. Cho also provides regulatory diligence to support transactions and securities filings in the life sciences industry and has experience representing pharmaceutical and medical device manufacturers in Hatch-Waxman litigations and product liability disputes.Get Access
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