Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

Summary

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).

Timeline

Start

2019-07-02

Primary completion

2022-04-22

Completion

2022-04-22

Outcome

Met primary endpoint

release “ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product” novartis.com ↗

Drugs

Indications