OBJECTIVE: The study assessed the efficacy, safety, pharmacokinetic (PK), and immunogenicity
profiles of denosumab‑biosimilar and denosumab‑reference in postmenopausal osteoporotic women
from India.
MATERIALS AND METHODS: In this randomized, assessor‑blind, active‑control, multicenter
trial, 114 patients were randomly allocated to receive denosumab‑biosimilar (n = 58) or
denosumab‑reference (n = 56) at a subcutaneous dose of 60 mg every 6 months, for a year. Vitamin
D and oral calcium were given daily. Lumbar spine bone mineral density (BMD) change was the
primary end point.
RESULTS: Of 114 randomized patients, 111 (denosumab‑biosimilar, n = 56; denosumab‑reference,
n = 55) completed the study. All 114 patients were part of safety and immunogenicity analyses,
110 (denosumab‑biosimilar, n = 56; denosumab‑reference, n = 54) were part of efficacy analysis,
and 20 (denosumab‑biosimilar, n = 10; denosumab‑reference, n = 10) were part of PK analysis. The
bone mineral density (BMD) (lumbar spine) percent change at 1 year with denosumab‑biosimilar
and denosumab‑reference (7.22 vs. 7.62; difference:−0.40; 95% confidence interval: −5.92, 5.12)
showed no statistically relevant difference. Likewise, alkaline phosphatase (bone‑specific) and PK
parameters also did not show statistically relevant differences. Adverse events were reported in
44.83% of patients on denosumab‑biosimilar versus 33.93% of patients on denosumab‑reference;
most events were mild or moderate and not related to the study drugs. No patients showed
anti‑denosumab antibody positivity.
CONCLUSIONS: Denosumab‑biosimilar and denosumab‑reference showed biosimilarity in
osteoporotic postmenopausal women. Availability of denosumab‑biosimilar provides a treatment
alternative for patients.