A randomized phase I clinical trial comparing the pharmacokinetic, safety, and immunogenicity of potential biosimilar recombinant human HER2 monoclonal antibody for injection and trastuzumab in healthy Chinese adults

References

• Torre LA, Siegel RL, Ward EM, et al. Global cancer incidence and mortality rates and trends–an update. Cancer Epidemiol Biomarkers Prev. 2016 Jan;25(1):16–27.
   PubMed Web of Science ®Google Scholar
• Burstein HJ. The distinctive nature of HER2-positive breast cancers. N Engl J Med. 2005 Oct 20;353(16):1652–1654.
   PubMed Web of Science ®Google Scholar
• FDA; Label of HERCEPTIN ® (trastuzumab) for injection, for intravenous use Initial U.S. Approval; 1998. [cited 2018]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf
   Google Scholar
• Blackwell K, Gligorov J, Jacobs I, et al. The global need for a trastuzumab biosimilar for patients with HER2-positive breast cancer. Clin Breast Cancer. 2018 Apr;18(2):95–113.
   PubMed Web of Science ®Google Scholar
• Uifalean A, Ilies M, Nicoara R, et al. Concepts and challenges of biosimilars in breast cancer: the emergence of trastuzumab biosimilars. Pharmaceutics. 2018 Sep 25;10(4). DOI:10.3390/pharmaceutics10040168.
   PubMed Web of Science ®Google Scholar
• Thill M. New frontiers in oncology: biosimilar monoclonal antibodies for the treatment of breast cancer. Expert Rev Anticancer Ther. 2015 Mar;15(3):331–338.
   PubMed Web of Science ®Google Scholar
• Cazap E, Jacobs I, McBride A, et al. Global acceptance of biosimilars: importance of regulatory consistency, education, and trust. Oncologist. 2018 Oct;23(10):1188–1198.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. Biosimilar product information. [cited 2020 Feb 24]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
   Google Scholar
• European Medicines Agency. Biosimilar information. [cited 2020 May 08]. Available from: https://www.ema.europa.eu/en/medicines/search_api_aggregation_ema_medicine_types/field_ema_med_biosimilar
   Google Scholar
• European Medicines Agency. Guideline on similar biological medicinal products; 2015. [cited 2015]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf
   Google Scholar
• World Health Organization guidelines on evaluation of similar biotherapeutic products (sbps): expert committee on biological standardization Geneva. Switzerland: World Health Organization; 2009. [cited 2017]. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
   Google Scholar
• FDA Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to aReference Product; U.S. Department of Health and Human Services, Food and DrugAdministration, Center for Drug Evaluation and Research (CDER), Center for BiologicsEvaluation and Research (CBER); 2015 [cited 2018]. Available from: https://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.
   Google Scholar
• European Medicines Agency Guideline on Similar Biological Medicinal Prodcuts Containing Monoclonal Antibodies – non-clinical and clinical issues; 2012 [cited 2012]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf
   Google Scholar
• Joshi S, Rathore AS. Assessment of structural and functional comparability of biosimilar products: trastuzumab as a case study. BioDrugs. 2020 Apr;34(2):209–223.
   PubMed Web of Science ®Google Scholar
• Wolff-Holz E, Tiitso K, Vleminckx C, et al. Evolution of the EU biosimilar framework: past and future. BioDrugs. 2019 Dec;33(6):621–634.
   PubMed Web of Science ®Google Scholar
• Hanes V, Chow V, Zhang N, et al. A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects. Cancer Chemother Pharmacol. 2017 May;79(5):881–888.
   PubMed Web of Science ®Google Scholar
• Waller CF, Vutikullird A, Lawrence TE, et al. A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs. EU-trastuzumab and US-trastuzumab. Br J Clin Pharmacol. 2018 Oct;84(10):2336–2343.
   PubMed Web of Science ®Google Scholar
• Yin D, Barker KB, Li R, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol. 2014 Dec;78(6):1281–1290.
   PubMed Web of Science ®Google Scholar
• Pivot X, Curtit E, Lee YJ, et al. A randomized phase I pharmacokinetic study comparing biosimilar candidate SB3 and trastuzumab in healthy male subjects. Clin Ther. 2016 Jul;38(7):1665–1673.e3.
   PubMed Web of Science ®Google Scholar
• Pivot X, Deslypere JP, Park LS, et al. A randomized phase I study comparing the pharmacokinetics of HD201, a trastuzumab biosimilar, with European union-sourced herceptin. Clin Ther. 2018 Mar;40(3):396–405.e4.
   PubMed Web of Science ®Google Scholar
• Wisman LA, De Cock EP, Reijers JA, et al. A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers. Clin Drug Investig. 2014 Dec;34(12):887–894.
   PubMed Web of Science ®Google Scholar
• Morita J, Tanaka M, Nomoto M, et al. Pharmacokinetic bioequivalence, safety, and Immunogenicity of DMB-3111, a trastuzumab biosimilar, and trastuzumab in healthy japanese adult males: results of a randomized trial. BioDrugs. 2016 Feb;30(1):17–25.
   PubMed Web of Science ®Google Scholar
• Esteva FJ, Stebbing J, Wood-Horrall RN, et al. A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab. Cancer Chemother Pharmacol. 2018 Mar;81(3):505–514.
   PubMed Web of Science ®Google Scholar
• Zhou X, Yu J, Wang W, et al. A phase I dose-escalation study of a biosimilar trastuzumab in Chinese metastasis breast cancer patients. SpringerPlus. 2015 Dec;4(1):803.
   PubMedGoogle Scholar
• Deng R, Iyer S, Theil FP, et al. Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: what have we learned? mAbs. 2011 Jan-Feb;3(1):61–66.
   PubMed Web of Science ®Google Scholar
• Wang J, Iyer S, Fielder PJ, et al. Projecting human pharmacokinetics of monoclonal antibodies from nonclinical data: comparative evaluation of prediction approaches in early drug development. Biopharm Drug Dispos. 2016 Mar;37(2):51–65.
   PubMed Web of Science ®Google Scholar
• Wang Q, Xie X, Su F, et al. A randomized controlled dose-escalation study of SSS07, a humanized rabbit anti-human TNF alpha antibody, in healthy Chinese adults. Int Immunopharmacol. 2019 Oct;75:105807.
   PubMed Web of Science ®Google Scholar
• Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394–424.
   PubMed Web of Science ®Google Scholar
• Yang L, Zheng R, Wang N, et al. Incidence and mortality of stomach cancer in China, 2014 [Article]. Chin J Cancer Res. 2018;30(3):291–298.
   PubMed Web of Science ®Google Scholar