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

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

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

Indications