Module 9 2024

05/09/2024

Totality of Data

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CMC

Non-clinical

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Physicochemical properties

Biological properties

Animal models

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Clinical Trials

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Similarity Assessment

PK/PD

Efficacy/Safety

The Organisation for Professionals in Regulatory Affairs

7

EU VS. US: DIFFERENT DEFINITIONS FOR BIOSIMILAR AND BIOLOGIC

The Organisation for Professionals in Regulatory Affairs

8

4