Module 9 2021

22/03/2021

BIOASSAYS = KEY PILLAR OF BIOSIMILARITY EXERCISE

Efficacy & Safety

Clinical

PK/PD

Nonclinical

Reducing Uncertainty

Analytical

Similarity Assessment with Reference

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IMPACT OF SMALL DIFFERENCE IN GLYCOFORMS

R e l a t i

• Small difference in glycoforms can have huge impact on in vitro activity

4

• Clinical effect not known

3

v e

From data presented by R Garnick Genentech 15/02/2007

2

A D C C

1

0 1%

2%

3%

4%

5%

6%

7%

% Afucosylated IgG

1

34

y

© 2015 DIA, Inc. All rights reserved.

34

17