Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12
Authors' conclusion
The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.
Study context
- Population
- Women with postmenopausal osteoporosis with lumbar spine or total hip T-score between −2.5 and −4randomized 1:1
- Participants
- 457 women
- Comparison
- SB16 vs reference denosumab
- Primary endpoint
- Percent change from baseline in lumbar spine BMD
- Follow-up
- Up to month 12
Methodological detailsphase 3, double-blind, multicenter, equivalence (biosimilarity), rerandomization at month 12 (continue or switch denosumab (DEN) to SB16)
- Phase 3
- Double-blind
- Multicenter
- Equivalence (biosimilarity)
- Rerandomization at month 12 (continue or switch DEN to SB16)
Primary result
As reported in the abstract
% change from baseline in lumbar spine BMD
LS mean difference in % change from baseline in lumbar spine bone mineral density (BMD), full analysis set
0.33%
90% CI −0.25 to 0.91
LS mean difference in % change from baseline in lumbar spine BMD, per-protocol set
0.39%
95% CI −0.36 to 1.13
Secondary outcomes
Secondary endpoints (BMD of lumbar spine at other time points, total hip, femoral neck; PK; PD: serum CTX, P1NP; safety; immunogenicity) · up to month 12
- Secondary endpoints comparable between the 2 treatment groups
Original publication
Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. Published 7 September 2024. doi:10.
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