Module 9 2021

22/03/2021

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.

5

SIMILARITY IS BASED ON TOTALITY OF THE DATA

CMC

Non-clinical

Physicochemical properties

Biological properties

Animal models

Clinical Trials

Similarity Assessment

PK/PD

Efficacy/Safety

6

3