Module 9 2021

22/03/2021

Masterclass

Lecture 7: Regulation of Biosimilars

4 April 2019

Cecil Nick, Vice President Technical PAREXEL

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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Learning Outcomes

 Global biosimilar regulatory requirements  Different approaches to similarity of quality attributes

 Understanding the relationship between quality attributes and the clinical safety & efficacy profile to accurately predict expected clinical similarity  What quality differences can be justified  Gain an understanding of navigating different clinical data requirements and their endpoints  What are the requirements for choice of reference product, interchangeability, ethnicity and need for data from local patients and conducting global studies?

 Non clinical and clinical data requirements  Extrapolation of data across indications  Interchangeability

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