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.