Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis

Phase 3 Completed 479 enrolled Biocon Biologics UK Ltd

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with osteoporosis

Timeline

Start: 2022-05-24
Primary completion: 2024-06-12
Completion: 2024-06-12

Outcome

Met primary endpoint

paper LSM diff: 0.610, 95% CI: -0.095, 1.316), indicating therapeutic equivalence. PMID 42110973 ↗

paper In conclusion, Bmab 1000 demonstrated equivalent efficacy and PD to reference denosumab PMID 42110973 ↗

Publications

Eastell R, Orwoll E, Cosman F, Plebanski R, Kumar K, Marwah A, Deodhar SS, Wolff-Holz E, Loganathan S. Efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of Bmab 1000 vs reference denosumab: 78-wk results from a randomized, double-blind, multicenter, parallel-arm Phase 3 trial (DEVOTE) in women with postmenopausal osteoporosis. JBMR Plus. 2026 Apr 11;10(6):ziag062. doi: 10.1093/jbmrpl/ziag062. eCollection 2026 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bmab 1000	Unknown	60 mg	Subcutaneous
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous