Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Summary

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.

Timeline

Start

2022-08-23

Primary completion

2024-05-07

Completion

2024-10-28

Outcome

Met primary endpoint

paper were entirely contained within the prespecified margin (-1.45%, 1.45%), supporting demonstration of comparative efficacy. PMID 40698538 ↗

paper were entirely contained within the prespecified margin (0.80, 1.25), supporting demonstration of pharmacodynamic similarity. PMID 40698538 ↗

release “The AVT03-GL-C01 study, which met its primary endpoints, demonstrated clinical similarity” alvotech.com ↗

Publications

• Lortkipanidze M, de Villiers T, Kania G, Bullo F, Jaskiewicz L, Stamatakos S, Rai M, Haliduola H, Otto H, Sattar A, Leutz S, Berti F. A randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis. Expert Opin Biol Ther. 2025 Aug;25(8):899-912. doi: 10.1080/14712598.2025.2538609. Epub 2025 Jul 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVT03	Unknown	60 mg	Subcutaneous
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous

Indications