Efficacy and safety of denosumab biosimilars in the treatment of postmenopausal osteoporosis: A systematic review of randomized clinical trials
Abstract
Denosumab biosimilars were developed to provide cost-effective alternatives to the reference monoclonal antibody for postmenopausal osteoporosis (PMO). This review assessed their efficacy, safety, and immunogenicity in the treatment of PMO. A systematic search of PubMed/Medline, Ovid-Embase, and Web of Science (to April 2025) identified randomized controlled trials comparing denosumab biosimilars with either the originator (Prolia®) or placebo. Data on bone mineral density (BMD), bone turnover markers, adverse events, and immunogenicity were synthesized descriptively. In addition, the National Institutes of Health (NIH) Quality Assessment Tool was employed to evaluate the risk of bias across all eligible studies. Eleven RCTs met the inclusion criteria. Biosimilars showed therapeutic equivalence to the reference product, with comparable BMD gains at the lumbar spine, total hip, and femoral neck, and similar reductions in CTX and P1NP. In placebo-controlled trials, biosimilars significantly increased BMD and reduced bone turnover by more than 70%. Safety and immunogenicity profiles were comparable to the originator, with no new safety signals or neutralizing antibodies. Denosumab biosimilars demonstrate efficacy and safety equivalent to Prolia®, offering an accessible, cost-efficient option for PMO management. Long-term data are needed to confirm sustained antifracture benefits.
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