Clin Osteol 2025; 30(2): 96-99
Biosimilar denosumab CT-P41 in the treatment of osteoporosisOriginal contributions
- Ústav farmakologie LF UP a FN Olomouc
Denosumab is an IgG2 monoclonal antibody targeted against receptor activator of nuclear factor kappa-B (RANKL) ligand, a key regulator of bone resorption by osteocytes. Therapy with this biologic is an effective and safe treatment option for osteoporosis of various aetiologies. Denosumab CT-P41 is a biosimilar that was registered by the European Medicines Agency in March 2025 under the name Stoboclo for use in osteology. In preclinical and clinical trials, it has demonstrated quality, safety and efficacy in the treatment of bone loss comparable to the brand-name. Its introduction into clinical practice will improve the availability of expensive biological treatment for osteoporosis.
Keywords: biosimilar, denosumab, osteoporosis.
Published: June 1, 2025 Show citation
References
- Matsumoto T, Endo I. RANKL as a target for the treatment of osteoporosis. J Bone Miner Metab. 2021 Jan;39(1):91-105.
- Bekker PJ, Holloway DL, Rasmussen AS, et al. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004 Jul;19(7):1059-66.
- SPC Stoboclo. Celltrion Healthcare Hungary Kft., 2025.
- Lamy O, Everts-Graber J, Rodriguez EG. Denosumab for osteoporosis treatment: when, how, for whom, and for how long. A pragmatical approach. Aging Clin Exp Res. 2025 Mar 8;37(1):70.
- Ha J, Lee YJ, Kim J, et al; Catholic Medical Center Bone Research Group. Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use. Endocrinol Metab (Seoul). 2025 Feb;40(1):47-56.
- Chen CL, Wang JY. Superiority of denosumab over bisphosphonates in preventing and treating glucocorticoid-induced osteoporosis: a systematic review and meta-analysis with GRADE quality assessment. Front Endocrinol (Lausanne). 2024 Dec 18;15:1407692. doi: 10.3389/fendo.2024
Go to original source... - Cummings SR, San Martin J, McClung MR, et al; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65.
- Bone HG, Wagman RB, Brandi ML, et al. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017 Jul;5(7):513-523.
- Jain S. Prevention and Management of Denosumab Discontinuation Rebound Fractures. Endocrinol Metab Clin North Am. 2024 Dec;53(4):559-583.
- Urbánek K. Generické léky: teorie a praxe. Klin Farmakol Farm. 2019;33(3):5-10.
- Kim A, Hong JH, Shin W, et al. A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males. Expert Opin Biol Ther. 2024 Jul;24(7):655-663.
- Reginster JY, Czerwinski E, Wilk K, et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930.
