Recorded October 6, 2021 | On-Demand Webinar
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.
This session was recorded as part of FDLI’s virtual Introduction to Biologics and Biosimilars Law and Regulation course in October 2021.