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A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar etanercept (GP2015) and Enbrel in patients with moderate to severe chronic plaque-type psoriasis

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Trial Profile

A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar etanercept (GP2015) and Enbrel in patients with moderate to severe chronic plaque-type psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 May 2019

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At a glance

  • Drugs Etanercept (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms EGALITY
  • Sponsors HEXAL; Sandoz

    • Most Recent Events

    • 17 Nov 2017 According to a Sandoz Canada media release, Erelzi has been granted Health Canada approval in April 2017. The approval was based on a comprehensive development program consisting of comparative analytical, preclinical, and clinical data including this trial.
    • 27 Jun 2017 According to a Sandoz media release, the European Commission (EC) has approved Erelzi for use in Europe. Erelzi is approved for use in all indications of the reference medicine, Enbrel. The approval was based on a comprehensive development program generating analytical, preclinical, and clinical studies including this trial.
    • 21 Apr 2017 According to a Sandoz media release, the Committee for Medicinal Products for Human Use (CHMP) of EMA has adopted positive opinion recommending approval of biosimilar etanercept to treat the same indications as the reference product (Enbrel). The recommendation was based on results from biosimilar development program that included this trial.
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