Understand background and definitions of biologic and biosimilar drugs and new drug applications (NDAs) and biologics license applications (BLAs). Summarize 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.
William Holtz, Principal, Leavitt Partners, LLC
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 October 2022.