Module 9 2021

22/03/2021

DIFFERENCES NEED TO BE JUSTIFIED

PyroE

PyroE

D D O O

D

D

O

O

G

G

D D

G G

K K

• Pharmacokinetics • Pharmacodynamics • Immunogenicity

• Safety • Efficacy

DIFFRENCES

7

7

EU VS. US: DIFFERENT

DEFINITIONS FOR BIOSIMILAR AND BIOLOGIC

8

4