Treatment of Inflammatory Bowel Disease with Biologics

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