An Introduction to Biosimilar Product Regulation and Approval

Review background and definitions of biologic and biosimilar drugs and new drug application (NDAs) and biologics license application (BLAs). Discuss biosimilar pathways to market and application contents. Learn about the types of meetings available to interact with FDA. Examine interchangeability standards and conditions of use.

Alexandra Valenti, Partner, Goodwin Procter LLP
Steven S. Tjoe, Senior Associate, Goodwine Procter LLP

This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in March 2022. 


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