title: Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study.
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.
  
  
  CONCLUSIONS
  The PK profile of CT-P13 is highly similar to EU-RMP and US-RMP. All three formulations were equally well tolerated.
authors.affiliation: a 1 Inha University Hospital, Incheon, Republic of Korea.
authors.forename: Won
authors.initials: W
authors.lastname: Park
authors.affiliation: b 2 Celltrion, Incheon, Republic of Korea.
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: b 2 Celltrion, Incheon, Republic of Korea.
authors.forename: Jihye
authors.initials: J
authors.lastname: Yun
authors.affiliation: c 3 Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 220 Wangsimni-Ro, Seongdong-Gu, Seoul 133-792, Republic of Korea.
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Yoo
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics*; D018501:Antirheumatic Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D059451:Biosimilar Pharmaceuticals / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D017277:Drug Approval; D005060:Europe; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D000069285:Infliximab / Q000493:pharmacokinetics*; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
keywords: CT-P13; European Union; USA; biosimilar; healthy subjects; infliximab; pharmacokinetics; safety