Webinar

Biosimilar and Interchangeable Products in the U.S.

December 5, 2018

On Monday, December 10, at 1:00 p.m. ET, join the FDA’s Division of Drug Information for a webinar on biosimilar and interchangeable products and the approval process in the U.S.

Specifically, the webinar will cover:

  • The difference between biosimilar and interchangeable products and how they are prescribed/dispensed
  • General components of the labeling for biosimilar products and the value of labeling to provide the product’s safety and effectiveness information to health care providers
  • Terminology used to describe various aspects of biosimilar and interchangeable products, and the development and approval process
  • The goals of a stand-alone and biosimilar development pathway and the stepwise evidence approach used to generate data in support of a demonstration of biosimilarity
  • The importance of the analytical foundation and how FDA assesses analytical similarity
  • Resources available to health care professionals about biosimilar and interchangeable products

To register, please visit the FDA website.