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A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive

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Trial Profile

A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Sep 2026

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Unspecified
  • Focus Pharmacokinetics; Registrational
  • Sponsors Alvotech

Most Recent Events

  • 31 Aug 2026 According to an Alvotech Media Release, company announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration.
  • 08 Jun 2026 According to an Alvotech Media Release, the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) lyophilized vial for intravenous administration.
  • 05 Feb 2026 According to an Alvotech Media Release, based on regulatory advice, the AVT80-GL-P01 clinical study is considered pivotal to support the demonstration of clinical similarity for AVT16 and AVT80.

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