A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade and US Sourced Remicade) in Healthy Subjects

Trial Profile

A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade and US Sourced Remicade) in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 12 Jul 2017

At a glance

  • Drugs Infliximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Samsung Bioepis
  • Most Recent Events

    • 30 May 2016 According to a Biogen media release, The European Commission (EC) has granted marketing authorization in the European Union (EU) for FLIXABI (Infliximab Biosimilar) based on the data from this and a phase III trial (see profile 235251).
    • 23 May 2016 According to Merck media release, Biologics License Application (BLA) of SB2 (infliximab) by Samsung Bioepis has been accepted for review by the U.S. Food and Drug Administration (FDA).
    • 01 Apr 2016 According to a Samsung Bioepis media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Flixabi, a biosimilar version of Remicade (infliximab).
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