Efficacy and safety of denosumab biosimilar CMAB807 versus Prolia in Chinese postmenopausal women with osteoporosis

A. Unnanuntana, B.P. Gladnick, E. Donnelly et al., The assessment of fracture risk. J. Bone Joint Surg. Am. 92(3), 743–753 (2010)

Article  PubMed  PubMed Central  Google Scholar 

T. Sözen, L. Özışık, N. Başaran, An overview and management of osteoporosis. Eur. J. Rheumatol. 4(1), 46–56 (2017)

Article  PubMed  Google Scholar 

Y.Y. Shen, X. Huang, J.Y. Wu et al., The global burden of osteoporosis, low bone mass, and its related fracture in 204 countries and territories, 1990–2019. Front. Endocrinol. 13, 882241 (2019)

Article  Google Scholar 

L.H. Wang, W. Yu, X.J. Yin et al., Prevalence of osteoporosis and fracture in china: the China osteoporosis prevalence study. JAMA Netw. Open. 4(8), e2121106 (2021)

D.M. Black, C.J. Rosen, C.G. Solomon, Clinical practive. Postmenopausal osteoporosis. N Engl. J. Med. 374(3), 254–262 (2016)

Article  CAS  PubMed  Google Scholar 

R. Eastell, T.W. O’Neill, L.C. Hofbauer et al., Postmenopausal osteoporosis. Nat. Rev. Dis. Primers. 2(1), 16069 (2016)

Article  PubMed  Google Scholar 

T.D. Rachner, S. khosla, L.C. Hofbauer et al., Osteoporosis: now and the future. Lancet. 377(9773), 1276–1287 (2011)

Article  CAS  PubMed  PubMed Central  Google Scholar 

J.R. Center, T.V. Nguyen, D. Schneider et al., Mortality after all major types of osteoporotic fracture in men and women: an observational study. Lancet. 353(9156), 878–882 (1999)

Article  CAS  PubMed  Google Scholar 

L. Si, T.M. Winzenberg, Q. Jiang, M. Chen, A.J. Palmer, Projection of osteoporosis-related fractures and costs in china: 2010–2050. Osteoporos. Int. 26(7), 1929–1937 (2015)

Article  CAS  PubMed  Google Scholar 

D.L. Lacey, W.J. Boyle, W.S. Simonet et al., Bench to bedside: Elucidation of the OPG-RANK-RANKL pathway and the development of denosumab. Nat. Rev. Drug Discov. 11(5), 401–419 (2012)

Article  CAS  PubMed  Google Scholar 

S.R. Cummings, M.J. San, M.R. Mcclung et al., Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Eng. J. Med. 361(8), 756–765 (2009)

Article  CAS  Google Scholar 

N. Freemantle, S. Satram-Hoang, E.T. Tang et al., Final results of the DAPS (Denosumab adherence preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos. Int. 23(1), 317–326 (2012)

Article  CAS  PubMed  Google Scholar 

H.J. Chen, W. Chen, F. Yuan et al., Pharmacokinetics, pharmacodynamics, safety and immunogenicity of CMAB807, a new denosumab biosimilar, in healthy Chinese subjects. Front. Pharmacol. 13, 821944 (2022)

Article  CAS  PubMed  PubMed Central  Google Scholar 

N.E. Storm, W. Chang, T.C. Lin et al., A novel case study of the use of Real-World evidence to support the registration of an osteoporosis product in China. Ther. Innov. Regul. Sci. 56(1), 137–144 (2022)

Article  PubMed  Google Scholar 

H. Zhang, J.M. Gu, A.J. Chao et al., A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk. Acta Pharmacol. Sin. 44(2), 446–453 (2023)

Article  CAS  PubMed  Google Scholar 

J.M. Gu, H. Zhang, Q.Y. Xue et al., Denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women: a randomized, double-blind, placebo-controlled, multicenter phase III study. J. Orthop. Translat. 38, 117–125 (2022)

Article  CAS  PubMed  PubMed Central  Google Scholar 

Y. Jiang, Y.N. Huo, Y.F. Li et al., Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. Expert Opin. Biol. Ther. 24(7), 665–672 (2024)

Article  CAS  PubMed  Google Scholar 

I. Singh, V. Jose, R. Patel, S. Arora, Denosumab biosimilar in postmenopausal osteoporotic women: A randomized, assessor-blind, active-controlled clinical trial. Indian J. Pharmacol. 53, 6–12 (2021)

Article  CAS  PubMed  PubMed Central  Google Scholar 

A. Jamshidi, M. Vojdanian, M. Soroush et al., Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two–armed, double–blind, parallel, active–controlled, and non-inferiority clinical trial. Arthritis Res. Ther. 24(1), 161 (2022)

Article  CAS  PubMed  PubMed Central  Google Scholar 

J.Y. Reginster, E. Czerwinski, K. Wilk 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. 35(11), 1919–1930 (2024)

Article  CAS  PubMed  PubMed Central  Google Scholar 

L. Bente, C. Yoon-Sok, P. Rafal et al., Proposed denosumab biosimilar SB16 vs reference denosumab in postmenopausal osteoporosis: phase 3 results up to month 12. J. Clin. Endocrinol. Metab. 110(6), e1951-e1958 (2025)

A. Roger, R.A. Hannon, R. Eastell, Biochemical markers as predictors of rates of bone loss after menopause. J. Bone Min. Res. 15(7), 1398–1404 (2000)

Article  Google Scholar 

S. Vasikaran, R. Eastell, O. Bruyère et al., Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos. Int. 22(2), 391–420 (2011)

Article  CAS  PubMed  Google Scholar 

T. Sugimoto, T. Matsumoto, T. Hosoi et al., Three-year denosumab treatment in postmenopausal Japanese women and men with osteoporosis: results from a 1-year open-label extension of the denosumab fracture intervention randomized placebo controlled trial (DIRECT). Osteoporos. Int. 26(2), 765–774 (2015)

Article  CAS  PubMed  Google Scholar 

P.J. Bekker, D.L. Holloway, A.S. Rasmussen et al., A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J. Bone Min. Res. 19(7), 1059–1066 (2004)

Article  CAS  Google Scholar 

P. Makras, S.A. Polyzos, A. Papatheodorou et al., Parathyroid hormone changes following denosumab treatment in postmenopausal osteoporosis. Clin. Endocrinol. (Oxf). 79(4), 499–503 (2013)

Article  CAS  PubMed  Google Scholar 

H.F. Gu, L.J. Gu, Y. Wu et al., Efficacy and safety of denosumab in postmenopausal women with osteoporosis: A Meta-Analysis. Med. (Baltim). 94(44), e1674 (2015)

K. Pittman, Y.C. Antill, A. Goldrick et al., Denosumab: prevention and management of hypocalcemia, osteonecrosis of the jaw and atypical fractures. Asia Pac. J. Clin. Oncol. 13(4), 266–276 (2017)

Article  PubMed  Google Scholar 

Comments (0)

No login
gif