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.
Khailee Marischuk, Law Graduate, Foley & Lardner LLP
David L. Rosen, Partner, Foley & Lardner LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2023.
KHAILEE MARISCHUK, PhD, JD, is a law graduate with Foley and Lardner LLP in the Chemical, Biotech, and Pharmaceutical Practice Group. Dr. Marischuk primarily works with biotechnology, pharmaceutical and life science companies to obtain and defend intellectual property rights. Dr. Marischuk’s experience covers a wide range of technologies, including CRISPR-Cas9 gene editing, RNA processing and expression, and genetic sequencing and expression analysis. Dr. Marischuk received her JD at the George Washington University Law School (2023). She earned her master’s degree and PhD in genetics at the University of Wisconsin-Madison (2017, 2019). Dr. Marischuk is admitted to practice before the U.S. Patent and Trademark Office.
DAVID L. ROSEN is a partner and public policy lawyer with Foley & Lardner LLP. He has extensive experience in health law, life sciences and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams. David was formerly a partner with two other law firms. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues and related compliance activities.Get Access
- +$100 for nonmembers
Internet Explorer and Microsoft Edge are not supported by the checkout process.
Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.
Virtual Learning FAQ
Related Content
