Module 9 2024

05/09/2024

Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products

Regulation of Biosimilars

Cecil Nick

Vice President Technical, PAREXEL

11 Sept 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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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

The Organisation for Professionals in Regulatory Affairs

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