Bmab 1000 (denosumab biosimilar) / Biocon, Yoshindo - LARVOL DELTA

A Randomized, Double-blind, Multicenter, Parallel-arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab-1000 and Prolia in Postmenopausal Women with Osteoporosis (ACR Convergence 2024) - "This study demonstrated equivalent efficacy (%CfB in lumbar spine BMD) and PD (sCTX, AUEC) between Bmab-1000 and Prolia®, with similar safety and tolerability profiles."

Clinical • P3 data • PK/PD data • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

DEVOTE: Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=480 | Completed | Sponsor: Biocon Biologics UK Ltd | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (clinicaltrials.gov) - P1 | N=190 | Completed | Sponsor: Biocon Biologics UK Ltd | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Oct 2023 | Trial primary completion date: Feb 2024 ➔ Oct 2023

Trial completion • Trial completion date • Trial primary completion date

DEVOTE: Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=480 | Active, not recruiting | Sponsor: Biocon Biologics UK Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Osteoporosis • Rheumatology

Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Male Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (clinicaltrials.gov) - P1 | N=190 | Active, not recruiting | Sponsor: Biocon Biologics UK Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed

DEVOTE: Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: Biocon Biologics UK Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Osteoporosis • Rheumatology