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Phase 1 randomized, single-blind, single-dose, 3 arm, parallel group PK similarity, safety, tolerability, immunogenicity and bridging between HUMIRA® (US) and HUMIRA® (EU) in healthy subjects

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Trial Profile

Phase 1 randomized, single-blind, single-dose, 3 arm, parallel group PK similarity, safety, tolerability, immunogenicity and bridging between HUMIRA® (US) and HUMIRA® (EU) in healthy subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Feb 2022

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Amgen

    • Most Recent Events

    • 02 Feb 2022 Results of retrospective analysis assessing PK equivalence between Adalimumab and ABP 501 in the presence of antidrug antibodies using population PK modeling, published in the Clinical Therapeutics
    • 04 May 2021 According to an Amgen media release, AMGEVITA was approved in Canada based on a robust data package supporting biosimilarity to the reference product, Humira, based on analytical, nonclinical, pharmacokinetic and clinical data, including results from two confirmatory clinical studies conducted in moderate-to-severe psoriasis (PsO) and moderate-to-severe rheumatoid arthritis (RA) patients.
    • 24 Oct 2018 Results presented at the 26th United European Gastroenterology Week
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