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.

Krista Hessler Carver, Partner, Covington & Burling LLP

This session was recorded as part of FDLI’s Virtual Introduction to Biologics  and Biosimilars Laws and Regulations Course in March/April 2020. 

 

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