Won Park1, Sang Joon Lee2, Jihye Yun2, Dae Hyun Yoo3. 1. a 1 Inha University Hospital, Incheon, Republic of Korea. 2. b 2 Celltrion, Incheon, Republic of Korea. 3. c 3 Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 220 Wangsimni-Ro, Seongdong-Gu, Seoul 133-792, Republic of Korea.
Abstract
OBJECTIVE: To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima(®), Inflectra(®)]) with two formulations of the reference medicinal product (RMP) (Remicade(®)) from either Europe (EU-RMP) or the USA (US-RMP). METHODS: This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013-003173-10). Healthy subjects received single doses (5 mg/kg) of CT-P13 (n = 71), EU-RMP (n = 71) or US-RMP (n = 71). The primary objective was to compare the PK profiles for the three formulations. Assessments of comparative safety and tolerability were secondary objectives. RESULTS: Baseline demographics were well balanced across the three groups. Primary end points (Cmax, AUClast and AUCinf) were equivalent between all formulations (CT-P13 vs EU-RMP; CT-P13 vs US-RMP; EU-RMP vs US-RMP). All other PK end points supported the high similarity of the three treatments. Tolerability profiles of the formulations were similar. CONCLUSION: The PK profile of CT-P13 is highly similar to EU-RMP and US-RMP. All three formulations were equally well tolerated.
RCT Entities:
OBJECTIVE: To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima(®), Inflectra(®)]) with two formulations of the reference medicinal product (RMP) (Remicade(®)) from either Europe (EU-RMP) or the USA (US-RMP). METHODS: This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013-003173-10). Healthy subjects received single doses (5 mg/kg) of CT-P13 (n = 71), EU-RMP (n = 71) or US-RMP (n = 71). The primary objective was to compare the PK profiles for the three formulations. Assessments of comparative safety and tolerability were secondary objectives. RESULTS: Baseline demographics were well balanced across the three groups. Primary end points (Cmax, AUClast and AUCinf) were equivalent between all formulations (CT-P13 vs EU-RMP; CT-P13 vs US-RMP; EU-RMP vs US-RMP). All other PK end points supported the high similarity of the three treatments. Tolerability profiles of the formulations were similar. CONCLUSION: The PK profile of CT-P13 is highly similar to EU-RMP and US-RMP. All three formulations were equally well tolerated.
Authors: E M H Schmitz; S Benoy-De Keuster; A J L Meier; V Scharnhorst; R A M Traksel; M A C Broeren; L J J Derijks Journal: Clin Rheumatol Date: 2017-06-07 Impact factor: 2.980
Authors: Renáta Bor; Klaudia Farkas; Anna Fábián; Anita Bálint; Ágnes Milassin; Mariann Rutka; Mária Matuz; Ferenc Nagy; Zoltán Szepes; Tamás Molnár Journal: PLoS One Date: 2017-03-31 Impact factor: 3.240
Authors: Vibeke Strand; Joao Gonçalves; Timothy P Hickling; Heather E Jones; Lisa Marshall; John D Isaacs Journal: BioDrugs Date: 2020-02 Impact factor: 5.807