A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Adalimumab (SB5, EU Sourced Humira and US Sourced Humira) 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 Adalimumab (SB5, EU Sourced Humira and US Sourced Humira) in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 13 Jul 2017

At a glance

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

    • 23 Jun 2017 According to Biogen media release, based on the data from preclinical and clinical data from this and other phase III study (NCT02167139), the CHMP of the European Medicines Agency (EMA) has issued a positive opinion for IMRALDI. The positive opinion will now be referred to the European Commission (EC) for marketing authorization in the European Union.
    • 17 Jul 2016 According to Biogen media release, the Marketing Authorization Application (MAA) for SB5, an adalimumab biosimilar candidate referencing Humira, has been accepted for review by the European Medicines Agency (EMA) based upon the data from preclinical and clinical data from this and other phase III study (NCT02167139).
    • 13 Jun 2015 Results presented at the 16th Annual Congress of the European League Against Rheumatism.
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