266
Clinical Criteria for Demonstration of Biosimilarity
Pharmacokinetic Analyses
The pharmacokinetic (PK) properties of CT-P13 were studied in a double-blind,
three-arm, parallel-group study of the biosimilar CT-P13 and two formulations of
Remicade® using healthy subjects receiving a single infusion dosed at 5 mg/kg of
US-licensed Remicade CT-P13 EU-infliximab
US-licensed Remicade CT-P13 EU-infliximab
27 lots
115.0
TNF-α Binding Affinity (ELISA)
110.0
105.0
TNF Binding Affinity (ELISA),%
100.0
95.0
90.0
85.0
80.0
13 lots
23 lots
In Vitro TNF-a Neutralization
16 lots
115
110
in Vitro TNF Neutralization, %
105
100
95
90
85
80
13 lots 13 lots
a
b
Fig.15.3 (a) Comparison of TNF binding by CT-P13,US reference infliximab and European
Union (EU) reference infliximab. (b) Comparison of TNF neutralization by CT-P13, US reference
infliximab and European Union (EU) reference infliximab Source: Ref. [ 10 ]
C.Y. Ha and A. Kornbluth