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: 30 Aug 2016

At a glance

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

    • 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
    • 13 Jul 2016 According to a Sandoz media release, the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. Data from this trial supported the recommendation.
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