EU-Prolia

BIOLOGICAL2 trials

Sponsors

mAbxience Research S.L., Luye Pharma Group Ltd.

Conditions

HealthyPostmenopausal Women With Osteoporosis

Phase 1

A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection

CompletedNCT06095427

Luye Pharma Group Ltd.Healthy

Start: 2021-03-09End: 2023-03-14Updated: 2023-10-23

Phase 3

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

CompletedNCT05338086

mAbxience Research S.L.Postmenopausal Women With Osteoporosis

Start: 2022-03-16End: 2024-05-22Updated: 2025-03-21

Related Papers

Phase III Study to Confirm Clinical Similarity of MB09, a Denosumab Biosimilar, and Prolia® in Postmenopausal Women with Osteoporosis (SIMBA Study)

Pharmaceutics2026-02-27

A three-arm clinical study to compare pharmacokinetic and pharmacodynamic similarity of the denosumab biosimilar LY06006 with reference denosumab in healthy male subjects

Expert Opinion on Drug Metabolism & Toxicology2024-11-24