Module 9 2024

05/09/2024

HOW SIMILAR IS BIOSIMILAR?

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Small differences can have large impact but some large difference may be inconsequential e.g. charge profile.

R e l a t i v e A D C C

•

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

4

•

Clinical effect not known

3

ADCC = Antigen Dependent Cellular Cytotoxicity

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

2

1

0

1%

2%

3%

4%

5%

6%

% Afucosylated IgG

1

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17