References
- Elango J, Bao B, Wu W. The hidden secrets of soluble RANKL in bone biology. Cytokine. 2021;144:155559. doi: 10.1016/j.cyto.2021.155559
- Zhang N, Zhang ZK, Yu Y, et al. Pros and cons of denosumab treatment for osteoporosis and implication for RANKL aptamer therapy. Front Cell Dev Biol. 2020;8. doi: 10.3389/fcell.2020.00325
- Eastell R, Christiansen C, Grauer A, et al. Effects of denosumab on bone turnover markers in postmenopausal osteoporosis. J of Bone & Mineral Res. 2011;26(3):530–537. doi: 10.1002/jbmr.251
- Bi H, Chen X, Gao S, et al. Key triggers of osteoclast-related diseases and available strategies for targeted therapies: a review. Front Med. 2017;4:4. doi: 10.3389/fmed.2017.00234
- Zhang Y, Liang J, Liu P, et al. The RANK/RANKL/OPG system and tumor bone metastasis: potential mechanisms and therapeutic strategies. Front Endocrinol. 2022;13. doi: 10.3389/fendo.2022.1063815
- EMA. Prolia EU SmPC [Internet]. 2020 [cited 2023 Aug 8]. Available from: https://www.ema.europa.eu/en/documents/product-information/prolia-epar-product-information_en.pdf
- FDA. Xgeva (denosumab) [US package insert]. 2022. [cited 2023 Dec 2]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s094lbl.pdf
- EMA. Xgeva EU SmPC [Internet]. 2016 [cited 2023 Aug 8]. Available from: https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf
- FDA. Prolia (denosumab) [US package insert]. Prolia (denosumab) [package insert]. 2023. [cited 2023 Dec 2]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s205lbl.pdf
- Karnon J, Shafie AS, Orji N, et al. What are we paying for? A cost-effectiveness analysis of patented denosumab and generic alendronate for postmenopausal osteoporotic women in Australia. Cost Eff Resour Alloc. 2016;14(1):11. doi: 10.1186/s12962-016-0060-5
- European Medicines Agency. Guideline on similar biological medicinal products [Internet]. 2014 [cited 2023 Sep 13]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf
- U.S. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance For Industry [Internet]. 2015 [cited 2023 Sep 13]. Available from: https://www.fda.gov/media/82647/download.
- Joshi D, Khursheed R, Gupta S, et al. Biosimilars in oncology: latest trends and regulatory status. Pharmaceutics. 2022;14(12):2721. doi: 10.3390/pharmaceutics14122721
- Jeka S, Dokoupilová E, Kivitz A, et al. Efficacy and safety of proposed denosumab biosimilar and reference denosumab in postmenopausal osteoporosis at 52 weeks: the ROSALIA study. In World congress on osteoporosis, osteoarthritis, and musculoskeletal diseases. Barcelona Spain: The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; The International Osteoporosis Foundation; 2023. p. OCT4.
- Jeka S, Dokoupilová E, Kivitz A, et al. Pharmacokinetics and pharmacodynamics of proposed denosumab biosimilar and reference denosumab in postmenopausal osteoporosis: the ROSALIA study. In World congress on osteoporosis, osteoarthritis, and musculoskeletal diseases. Barcelona Spain: The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; The International Osteoporosis Foundation; 2023. p. P303.
- Sutjandra L, Rodriguez RD, Doshi S, et al. Population pharmacokinetic meta-analysis of denosumab in healthy subjects and postmenopausal women with osteopenia or osteoporosis. Clin Pharmacokinet. 2011;50(12):793–807. doi: 10.2165/11594240-000000000-00000
- Zheng J, van Schaick E, Wu LS, et al. Using early biomarker data to predict long-term bone mineral density: application of semi-mechanistic bone cycle model on denosumab data. J Pharmacokinet Pharmacodyn. 2015;42(4):333–347. doi: 10.1007/s10928-015-9422-4
- Nakamura T, Matsumoto T, Sugimoto T, et al. Dose–response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. Osteoporos Int. 2012;23(3):1131–1140. doi: 10.1007/s00198-011-1786-8
- FDA. Bioanalytical method validation. Guidance for industry. 2018 [Internet]. [cited 2024 Jan 11]. Available from: https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
- EMA. Guideline on bioanalytical method validation. 2012 [Internet]. [cited 2024 Jan 11]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf
- EMA. ICH guideline M10 on bioanalytical method validation. 2023 [Internet]. [cited 2024 Jan 11]. Available from: https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation-scientific-guideline
- Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15(6):657–680. doi: 10.1007/BF01068419
- Amgen Inc. Xgeva US PI [Internet]. 2020 [cited 2023 Aug 8]. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Xgeva/xgeva_pi.pdf
- FDA. Immunogenicity information in human prescription therapeutic protein and select drug product labeling — content and format guidance for industry.
- FDA. Immunogenicity testing of therapeutic protein products — developing and validating assays for anti-drug antibody detection. Guidance For Industry. 2019.
- Soldin OP, Mattison DR. Sex differences in pharmacokinetics and pharmacodynamics. Clin Pharmacokinet. 2009;48(3):143–157. doi: 10.2165/00003088-200948030-00001
- Franconi F, Campesi I. Pharmacogenomics, pharmacokinetics and pharmacodynamics: interaction with biological differences between men and women. Br J Pharmacol. 2014;171(3):580–594. doi: 10.1111/bph.12362
- Szulc P, Naylor K, Hoyle NR, et al. Use of CTX-I and PINP as bone turnover markers: national bone health alliance recommendations to standardize sample handling and patient preparation to reduce pre-analytical variability. Osteoporos Int. 2017;28(9):2541–2556. doi: 10.1007/s00198-017-4082-4
- Michelsen J, Wallaschofski H, Friedrich N, et al. Reference intervals for serum concentrations of three bone turnover markers for men and women. Bone. 2013;57(2):399–404. doi: 10.1016/j.bone.2013.09.010
- García JJ, Raez LE, Rosas D. A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation. Transl Lung Cancer Res. 2020;9(5):2113–2119. doi: 10.21037/tlcr-20-601
- Matsumoto T, Endo I. RANKL as a target for the treatment of osteoporosis. J Bone Miner Metab. 2021;39(1):91–105. doi: 10.1007/s00774-020-01153-7
- Hou J, Hu Z, Xu W, 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. doi: 10.1016/j.intimp.2022.108666
- Lin Y, Yang H, Yang X, et al. Biosimilarity of HS-20090 to denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study. Expert Opin Investig Drugs. 2022;31(10):1125–1132. doi: 10.1080/13543784.2022.2123737
- Humphreys SZ. Real-world evidence of a successful biosimilar adoption program. Future Oncol. 2022;18(16):1997–2006. doi: 10.2217/fon-2021-1584