A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.

Phase 3 Completed 558 enrolled mAbxience Research S.L.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis

Timeline

Start: 2022-03-16
Primary completion: 2023-12-14
Completion: 2024-05-22

Outcome

Met primary endpoint

paper At month 12, %CfB in lumbar spine BMD was comparable between groups (MB09 versus Prolia) and met the predefined equivalence margins. PMID 41900779 ↗

Publications

Supronik J, Giorgadze E, Blicharski T, Sanchez-Vidaurre S, Perez-Diaz L, Paravisini A, Millan S. Phase III Study to Confirm Clinical Similarity of MB09, a Denosumab Biosimilar, and Prolia(R) in Postmenopausal Women with Osteoporosis (SIMBA Study). Pharmaceutics. 2026 Feb 27;18(3):291. doi: 10.3390/pharmaceutics18030291.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous
Subject	MB09	Unknown	60 mg	Subcutaneous