Overview

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Status:
Active, not recruiting

Trial end date:
2022-12-29

Target enrollment:

Participant gender:

Summary

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

Phase:

Phase 3

Details

Lead Sponsor:

Samsung Bioepis Co., Ltd.

Treatments:

Denosumab