• Phase 1 study for SB16, proposed biosimilar to Prolia, demonstrates pharmacokinetic (PK) bioequivalence between SB16, EU-sourced denosumab, and US-sourced denosumab in healthy male study participants
• Phase 3 study shows biosimilarity of SB16 with reference denosumab through equivalent efficacy and comparable pharmacodynamics (PD), PK, immunogenicity, and safety up to Month 12

The Phase 1 study was a randomized, double-blind, three-arm, multi-center, parallel group and single-dose study to demonstrate the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants. The primary PK endpoints were area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration. All of the corresponding 90% Confidence Intervals (CIs) of geometric least squares means (LSMeans) ratio of primary PK parameters for comparison of SB16 and EU-DEN, SB16 and US-DEN, and EU-DEN and US-DEN were within the pre-defined equivalence margin (0.80-1.25).

The Phase 3 study was a randomized double-blind study to compare efficacy, safety, PK, pharmacodynamics (PD) and immunogenicity of SB16 with reference denosumab in postmenopausal osteoporosis (PMO) patients. The study met its primary endpoints – percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 12 – with the difference in LSMeans % of 0.39 for per-protocol set (95% CI: −0.36 - 1.13), 0.33 for full analysis set (90% CI: −0.25 - 0.91), being fully contained within the pre-defined equivalence margin.

“We are pleased to present clinical data for SB16 for the first time at the ASBMR Annual Meeting. Through Phase 1 and 3 clinical studies, SB16 demonstrated biosimilarity to reference denosumab, meeting all the primary endpoints in both studies,” said Ilsun Hong, Vice President and Product Evaluation Team Leader at Samsung Bioepis. “As we continue to advance with our biosimilar development, our endeavors to enhance understanding of biosimilars among healthcare professionals will continue through our scientific research, publication and educational activities,” she added.