Denosumab Biosimilars Versus Denosumab in Postmenopausal Osteoporosis: Updated Systematic Review and Meta-Analysis of Randomized Trials.

CONTEXT: Denosumab is one of the first-line drugs for postmenopausal osteoporosis with high risk of fracture, but the cost limits its use. Denosumab biosimilars are a more affordable solution, though it is underutilized due to hesitation among clinicians and patients due to concerns for differences in efficacy and safety.

METHODS

We conducted an updated meta-analysis of randomized controlled trials (RCTs) comparing efficacy and safety of denosumab biosimilars to denosumab. PubMed, Embase, Cochrane databases and Clinical Trials.gov were searched for studies comparing denosumab biosimilars to denosumab in postmenopausal osteoporosis. We pooled mean differences (MD) for continuous outcomes and risk ratios (RR) for binary outcomes, with 95% confidence intervals (95% CIs). Heterogeneity was assessed using REML-based I2 statistics and Cochran's Q test. Statistical analyses were performed using R version 4.6.0.

RESULTS

Fourteen RCTs comprising 5595 participants were included, of whom 2825 participants (50.5%) received biosimilars. There was no statistical difference between percent change from baseline at 6 and 12 months respectively for lumbar spine bone mineral density (BMD), total hip, femoral neck BMD between the two groups. Similarly, change in C-telopeptide, procollagen type 1 N-terminal propeptide levels at 1, 6 and 12 months from baseline and vertebral fractures were similar between the two groups. There was no difference between the two groups in terms of safety outcomes including treatment-emergent adverse events (TEAE), grade ≥ 3 TEAEs.

CONCLUSION

Denosumab biosimilars were comparable in efficacy and short-term safety compared to denosumab in postmenopausal osteoporosis.