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Tutorial 06: BIOSIMILAR DEVELOPMENT- WHAT ARE THE CURRENT CHALLENGES?

Tutorial name:
Tutorial 06: BIOSIMILAR DEVELOPMENT- WHAT ARE THE CURRENT CHALLENGES?

Day & Time:
March 25, 9:00AM - 12:30PM (Central European Standard Time)

Room Number:
Room O

Registration Fees
- Standard Rate€400.00


Description:
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.

Learning Objective(s):
At the conclusion of this tutorial, participants should 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

Target Audience:
Professionals involved in the development of Biosimilars