Recorded October 19, 2023 | On-Demand Webinar
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.
This session was recorded as part of FDLI’s virtual course, "Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies" in October 2023.