Module 9 2021

22/03/2021

GLOBAL BIOSIMILAR PROGRAM Plan Ahead

PK/PD study

Global patient study

India, Russia

Global Efficacy Study vs. EU RMP

EU RoW

1 or 2 year Safety Extension

China

Separate ethnicity trials in Chinese, patients??

HV PK/PD bridging study in Japan

Japan

3-way PK study with BS vs. EU RMP vs. US RMP

USA

23

STRUCTURAL & BIOLOGICAL ANALYSIS - CMC

24

12