Module 9 2024

05/09/2024

Evolving Views

EMA Concept Paper: Considering the advances in the analytical sciences and the extensive regulatory experience gained, in vivo non clinical data and, at least for some less complex biologicals with a straightforward mechanism of action, the importance of dedicated clinical efficacy and safety data should be re-evaluated . Currently, the need for Comparative Efficacy Studies (CES) is increasingly questioned in general. Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development (europa.eu) WHO revised guidance notes that structural and functional aspects are a prerequisite for establishing comparability with a tailored clinical data package required as needed. And immunogenicity studies may not be necessary for well characterised biological substances .

2022

2024

The Organisation for Professionals in Regulatory Affairs

19

GLOBAL BIOSIMILAR DEVELOPMENT

The Organisation for Professionals in Regulatory Affairs

20

10