Comparative efficacy of biosimilar denosumab and reference denosumab in treatment of postmenopausal osteoporosis: a systematic review and meta-analysis.

Abstract

This meta-analysis addressed limited comparative evidence between reference and biosimilar denosumab. Across seven RCTs, both showed equivalent lumbar spine BMD, with a small hip BMD advantage for reference denosumab, supporting biosimilars as effective, safe, and cost-efficient alternatives. Osteoporosis is the most prevalent metabolic bone disorder in postmenopausal women. Addressing the gap in literature, our study compares efficacy of reference and biosimilar denosumab in treatment of postmenopausal osteoporosis. Following PRISMA guidelines, we systematically searched PubMed, Google Scholar, and Cochrane Library. Only randomized control trials (RCTs) comparing original denosumab with biosimilar denosumab conducted in postmenopausal women diagnosed with osteoporosis aged ≥ 45 years were included with Lumbar Spine-Bone Mineral Density (LS BMD) as primary outcome. Analysis was conducted using a random effects model on RevMan 5.4.1. Seven RCTs (n = 2251) were included. Both groups showed comparable LS BMD (MD = 0.02; 95% CI -0.30, 0.34; P = 0.92), while Total Hip BMD (TH BMD) was significantly improved with reference denosumab use (MD = 0.24; 95% CI 0.01, 0.47; P = 0.04). Bone turnover markers, fractures, TAEs, and ADA positivity showed no significant differences. Biosimilar denosumab demonstrates comparable efficacy, safety and immunogenicity to reference denosumab. Although, studies are necessary to monitor the efficacy and safety of biosimilar denosumab in long term use and different populations.