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A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Trial Profile

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms ADACCESS
  • Sponsors HEXAL; Novartis; Sandoz
  • Most Recent Events

    • 20 Nov 2018 Results published in the BioDrugs
    • 31 Oct 2018 According to a Sandoz media release, the US FDA has approved biosimilar, Hyrimoz (adalimumab-adaz) for all indications of reference medicine not protected by orphan exclusivity in US.The The FDA approval of Hyrimoz was based on a comprehensive data package comprising analytical, preclinical and clinical research which also included data from this study and other biosimilarity study (291439).
    • 27 Jul 2018 According to a Sandoz media release, the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz (adalimumab) for use in rheumatoid arthritis, plaque psoriasis, Crohns disease, uveitis and ulcerative colitis. The approval was based this and other trial (see profile 291439).
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