References
- Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993Jun; 94(6):646–650. PMID: 8506892.
- Rahmani P, Morin S. Prevention of osteoporosis-related fractures among postmenopausal women and older men. Cmaj. 2009 Nov 24;181(11):815–820. Epub 2009 Oct 19. PMID: 19841053; PMCID: PMC2780487.
- Chinese Society of Osteoporosis and Bone Mineral Research. Guidelines for the diagnosis and management of primary osteoporosis (2017). Chin J Osteoporos. 2019;25(3): doi:10.3969/j.1006-7108.2019.03.001.
- Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009Aug20;361(8):756–765. Epub 2009 Aug 11. Erratum in: N Engl J Med. 2009 Nov 5;361(19):1914. PMID: 19671655.
- Cosman F, de Beur SJ, LeBoff MS, et al. Clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014Oct;25(10):2359–2381. Epub 2014 Aug 15. Erratum in: Osteoporos Int. 2015 Jul;26(7):2045-7. PMID: 25182228; PMCID: PMC4176573
- Kim SY, Ok HG, Birkenmaier C, et al. Can denosumab be a substitute, competitor, or complement to bisphosphonates? Korean J Pain. 2017Apr;30(2):86–92. Epub 2017 Mar 31. PMID: 28416991; PMCID: PMC5392661
- US Food and Drug Administration. DEPARTMENT OF HEALTH AND HUMAN SERVICES, BLA 125320/S-186 [cited 2018 May 18]. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320Orig1s186ltr.pdf
- Giuliani J, Fiorica F, Albanese V, et al. Financial toxicity and cancer treatments: help from biosimilars - The explanatory case of bevacizumab. Eur J Cancer. 2021 Jan;143:40–42. Epub 2020 Dec 2. PMID: 33278773
- Center for Drug Evaluation, China. Technical guidelines for the development and evaluation of biosimilars [cite 2015 Feb 28]. http://www.cde.org.cn/zdyz.do?method=largePage&id=2f41e8f3c64fedad.
- Center for Drug Evaluation, China. Guidelines for design of clinical trials of denosumab injection biosimilars (osteoporosis indications) (draft for comment). 2020 [cited 2020 June 5]. https://www.cde.org.cn/main/news/viewInfoCommon/1b7602646b1f919e80c1cc2976f4af52
- National Medical Products Administration, China. Good clinical practice for drugs [cited 2020 July 1]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200426162401243.html
- Zaheer S, LeBoff M, Lewiecki EM. Denosumab for the treatment of osteoporosis. Expert Opin Drug Metab Toxicol. 2015Mar;11(3):461–470. Epub 2015 Jan 22. PMID: 25614274; PMCID: PMC4480604.
- Hou J, Zhitian H, Wenyu X, et al. The similarity of pharmacokinetics, pharmacodynamics, safety, and immunogenicity between recombinant fully human anti-RANKL monoclonal antibody injection (MW032) and denosumab (Xgeva®) in healthy Chinese subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled clinical study. Int Immunopharmacol. 2022;107:108666.
- US Food and Drug Administration. 2010. Label of Xgeva (Denosumab) injection, for subcutaneous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s203lbl.pdf
- Chen Q, Chaoying H, Liu Y, et al. Pharmacokinetics, pharmacodynamics, safety, and tolerability of single-dose denosumab in healthy Chinese volunteers: a randomized, single-blind, placebo-controlled study. PLoS ONE. 2018;13(6). DOI:10.1371/journal.pone.0197984
- Zhang H, Wu M, Zhu X, et al. A phase I, randomized, single-dose study to evaluate the biosimilarity of QL1206 to denosumab among Chinese healthy subjects. Front Pharmacol. 2020 Oct 8;11:01329. PMID: 33132906; PMCID: PMC7580200.
- Weibo, XIA. Chinese expert recommendations on the clinical rational use of denosumab in osteoporosis. Chin Soc Osteopors Bone Miner Res. 2020 November 10;13(6):499–508.
- Center for Drug Evaluation, China. Technical guidelines for clinical pharmacokinetic research of chemical drugs. 2005. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=4247ffceca57f2b47aa0f67a3fdc7c43.