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A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi, and EU-approved Simponi in Healthy Adult Participants

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Trial Profile

A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi, and EU-approved Simponi in Healthy Adult Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Golimumab (Primary)
  • Indications Immunological disorders; Rheumatoid arthritis
  • Focus First in man; Pharmacokinetics
  • Sponsors Alvotech

Most Recent Events

  • 27 Jan 2025 According to an Alvotech Media Release, the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025.
  • 15 Jun 2024 Results assessing pharmacokinetic similarity between Avt05 and reference presented at the 25th Annual Congress of the European League Against Rheumatism
  • 29 Nov 2023 Primary endpoint (To demonstrate the PK similarity of AVT05 with US licensed and EU approved Simponi and the PK of EU approved Simponi with US licensed Simponi) has been met as per results published in the Alvotech Media Release

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