Module 9 2024

05/09/2024

DIFFERENT PROCESS = DIFFERENT PRODUCT? Structure of biosimilars cannot be manufactured to be identical to the original product introducing a degree of uncertainty as to the benefit risk profile compared to original biologic.

The Organisation for Professionals in Regulatory Affairs

5

Biosimilarity is Not Just One Thing

Variants

Structure

Function

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Biosimilarity

Formulation

Aggregates

Container Closure

The Organisation for Professionals in Regulatory Affairs

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3