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Clinical Trial
. 2025 May 19;110(6):e1951-e1958.
doi: 10.1210/clinem/dgae611.

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

Bente Langdahl  1 , Yoon-Sok Chung  2   3 , Rafal Plebanski  4 , Edward Czerwinski  5 , Eva Dokoupilova  6   7 , Jerzy Supronik  8 , Jan Rosa  9 , Andrzej Mydlak  10 , Anna Rowińska-Osuch  11 , Ki-Hyun Baek  12 , Audrone Urboniene  13 , Robert Mordaka  14 , Sohui Ahn  15 , Young Hee Rho  16 , Jisuk Ban  16 , Richard Eastell  17
Affiliations
Clinical Trial

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

Bente Langdahl et al. J Clin Endocrinol Metab. .

Abstract

Context: SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia).

Objective: This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959).

Design: The study included 457 postmenopausal osteoporosis patients who had a lumbar spine or total hip T-score between -2.5 and -4. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at month 0 and month 6. At month 12, patients were rerandomized to continue with the assigned treatment or switch from DEN to SB16 up to month 18. This report includes results up to month 12.

Methods: The primary endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12. Secondary endpoints including the percent change from baseline in BMD of the lumbar spine (except for month 12), total hip, and femoral neck; pharmacokinetic, pharmacodynamic (serum C-telopeptide of type I collagen, and procollagen type I N-terminal propeptide), safety, and immunogenicity profiles were measured up to month 12.

Results: The least-squares mean differences in percent change from baseline in lumbar spine BMD at month 12 were 0.33% (90% CI, -0.25 to 0.91) in the full analysis set and 0.39% (95% CI, -0.36 to 1.13) in the per-protocol set; both within the predefined equivalence margin. The secondary endpoints were comparable between the 2 treatment groups.

Conclusion: The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.

Keywords: clinical trials; menopause; metabolic bone disease; osteoporosis.

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Figures

Figure 1.
Figure 1.
Patient disposition up to month 12. If a patient discontinued the study before rerandomization at month 12 but performed the BMD assessment at month 12 (eg, at an early termination visit), the patient was considered to have completed the main period. For this reason, 6 patients from the SB16 group and 4 patients from the DEN group were counted as completers despite discontinuation.
Figure 2.
Figure 2.
Changes in BMD up to month 12 (FAS). Mean (SE) percent changes from baseline in lumbar spine BMD (A), total hip BMD (B), and femoral neck BMD (C) up to month 12.
Figure 3.
Figure 3.
Changes in bone turnover marker concentrations up to month 12 (PDS). Median (IQR) percent changes from baseline in serum CTX (A) and serum P1NP (B) concentration profiles up to month 12.
See this image and copyright information in PMC

References

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    1. Consensus development conference: prophylaxis and treatment of osteoporosis. Am J Med. 1991;90(1):107‐110. Doi: 10.1016/0002-9343(91)90512-v - DOI - PubMed
    1. European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) . Guideline on the Evaluation of Medicinal Products in the Treatment of Primary Osteoporosis- Rev. 2. 2006. Accessed July 22, 2024. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-ev...
    1. Eastell R, Rosen CJ, Black DM, Cheung AM, Murad MH, Shoback D. Pharmacological management of osteoporosis in postmenopausal women: an endocrine society* clinical practice guideline. J Clin Endocrinol Metab. 2019;104(5):1595‐1622. - PubMed
    1. European Medicines Agency (EMA) . Summary of Product Characteristics of Prolia. September 2023. Accessed July 22, 2024. https://www.ema.europa.eu/en/documents/product-information/prolia-epar-p...

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