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A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND

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Trial Profile

A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ALVOBOND
  • Sponsors Alvotech

Most Recent Events

  • 18 Mar 2025 According to an Alvotech media release, the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia (denosumab) and Xgeva (denosumab).
  • 14 Nov 2024 According to an Alvotech media release, the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for AVT03.
  • 01 Nov 2024 Status changed from active, no longer recruiting to completed.

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