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A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia) in Patients With Postmenopausal Osteoporosis

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A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia) in Patients With Postmenopausal Osteoporosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2024

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Teva Pharmaceuticals USA

    • Most Recent Events

    • 08 Oct 2024 Accoding to Teva Pharmaceutical media release, company has announced that the US FDA has accepted Biologics License Application, and the EMA has validated Marketing Authorization Application for TVB-009P, a biosimilar candidate to Prolia (denosumab). The FDA decision and EMA opinion about applications are anticipated in the second half of 2025. The submissions are supported by results from this phase 3 trial.
    • 21 Jun 2023 Status changed from active, no longer recruiting to completed.
    • 01 Feb 2023 Planned End Date changed from 31 Dec 2023 to 15 Jul 2023.

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