Tutorial 06: BIOSIMILAR DEVELOPMENT- WHAT ARE THE CURRENT CHALLENGES?
Mar 25 2014 9:00AM - Mar 25 2014 12:30PM | Austria Center Vienna
This interactive tutorial will provide an overview of the key steps required for developing a biosimilar, the differences between biosimilars and non-comparable biologics and worldwide guidelines for and regulation of biosimilars. It will provide an in-depth understanding of the key principles for evaluating biosimilars, and give examples that highlight the importance of clinical trials for detecting clinically meaningful differences. The tutorial will explain the need for a separate biosimilars’ pathway to the generics pathway as well as the importance of unique naming for biosimilars.
Who Should Attend
Professionals involved in the development of Biosimilars
At the conclusion of this tutorial, attendees will be able to:
· Describe the differences between biosimilars and non-comparable biologics
· Describe the key worldwide regulations and guidelines for biosimilars
· Describe the key principles for evaluating biosimilars
· Discuss the different risk management needs between biosimilars and generics