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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

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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Jan 2020

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At a glance

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

    • Most Recent Events

    • 24 Aug 2017 According to Biogen media release, based on the data from preclinical and clinical data from this and other phase III study (NCT02167139), the European Commission (EC) granted a marketing authorization for IMRALDI for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn's disease, pediatric Crohn's disease, ulcerative colitis and uveitis.
    • 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).
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