A comparative pharmacokinetic study of Etanercept (GP2015) in healthy volunteers

Trial Profile

A comparative pharmacokinetic study of Etanercept (GP2015) in healthy volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 27 Jun 2017

At a glance

  • Drugs Etanercept (Primary)
  • Indications Ankylosing spondylitis; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis
  • Focus Pharmacokinetics
  • Most Recent Events

    • 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.
    • 30 Aug 2016 According to a Sandoz media release, the US FDA has approved biosimilar etanercept (Erelzi) for all indication included in the reference product label. Data from this and four other trials supported the approval.
    • 26 Jul 2016 New trial record
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