Efficacy and safety of biosimilar trastuzumab (CT-P6) in routine clinical practice in the Republic of Korea: a real-world post-marketing surveillance study

References

• Swain SM, Shastry M, Hamilton E. Targeting HER2-positive breast cancer: advances and future directions. Nat Rev Drug Discov. 2023;22(2):101–126. doi: 10.1038/s41573-022-00579-0
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. Herceptin® (trastuzumab) for injection, for intravenous use. US prescribing information. [internet]. 2018 Nov [cited 2023 Aug 2]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf
   Google Scholar
• Bradley R, Braybrooke J, Gray R, et al. Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials. Lancet Oncol. 2021;22(8):1139–1150. doi: 10.1016/S1470-2045(21)00288-6
   PubMed Web of Science ®Google Scholar
• Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687–697. doi: 10.1016/S0140-6736(10)61121-X
   PubMed Web of Science ®Google Scholar
• Kim TH, Do Cho H, Choi YW, et al. Trastuzumab-based palliative chemotherapy for HER2-positive gastric cancer: a single-center real-world data. BMC Cancer. 2021;21(1):325. doi: 10.1186/s12885-021-08058-2
   PubMed Web of Science ®Google Scholar
• Lluch-Gomez J, Nunez-Alvarez V, de la Torre-Hita C, et al. Real world evidence of adjuvant trastuzumab in HER2 positive early breast cancer. Sci Rep. 2023;13(1):7168. doi: 10.1038/s41598-023-34429-9
   PubMed Web of Science ®Google Scholar
• Kristin E, Endarti D, Khoe LC, et al. Does trastuzumab offer good value for money for breast cancer patients with metastasis in Indonesia? Asian Pac J Cancer Prev. 2022;23(7):2441–2447. doi: 10.31557/APJCP.2022.23.7.2441
   PubMedGoogle Scholar
• Gershon N, Berchenko Y, Hall PS, et al. Cost effectiveness and affordability of trastuzumab in sub-saharan Africa for early stage HER2-positive breast cancer. Cost Eff Resour Alloc. 2019;17(1):5. doi: 10.1186/s12962-019-0174-7
   PubMedGoogle Scholar
• Barrios CH, Reinert T, Werutsky G. Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab. Ecancermedicalscience. 2019;13:898. doi: 10.3332/ecancer.2019.898
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Biosimilar medicines: overview [internet]. 2023 [cited 2023 Aug 2]. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview
   Google Scholar
• Leung JH, Tai YS, Wang SY, et al. Cost-effectiveness of trastuzumab biosimilar combination therapy and drug wastage as first-line treatment for HER2-positive metastatic breast cancer. Breast. 2022;65:91–97. doi: 10.1016/j.breast.2022.07.007
   PubMed Web of Science ®Google Scholar
• Lee SM, Jung JH, Suh D, et al. Budget impact of switching to biosimilar trastuzumab (CT-P6) for the treatment of breast cancer and gastric cancer in 28 European countries. BioDrugs. 2019;33(4):423–436. doi: 10.1007/s40259-019-00359-0
   PubMed Web of Science ®Google Scholar
• Korean Ministry of Food and Drug Safety. Biological products. (recombinant DNA products) Celltrion Inc. [internet]. 2016 Mar 24 [cited 2023 Aug 18]. Available from: https://www.mfds.go.kr/eng/brd/m_30/view.do?seq=69797
   Google Scholar
• US Food and Drug Administration. Herzuma® (trastuzumab-pkrb) for injection, for intravenous use. US Prescribing Information [Internet]. 2019 May [cited 2023 Aug 2]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf
   Google Scholar
• European Medicines Agency. Herzuma summary of product characteristics [internet]. 2023 [cited 2023 Aug 2]. Available from: https://www.ema.europa.eu/en/documents/product-information/herzuma-epar-product-information_en.pdf
   Google Scholar
• Fu C, Stebbing J, Esteva FJ. Clinical development of CT-P6 in HER2 positive breast cancer. Expert Opin Biol Ther. 2019;19(10):987–992. doi: 10.1080/14712598.2019.1665019
   PubMed Web of Science ®Google Scholar
• Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017;18(7):917–928. doi: 10.1016/S1470-2045(17)30434-5
   PubMed Web of Science ®Google Scholar
• Stebbing J, Baranau YV, Baryash V, et al. Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial. Breast Cancer Res Treat. 2021;188(3):631–640. doi: 10.1007/s10549-021-06240-5
   PubMed Web of Science ®Google Scholar
• Stebbing J, Baranau Y, Baryash V, et al. Six-year survival outcomes for patients with HER2-positive early breast cancer treated with CT-P6 or reference trastuzumab: observational follow-up study of a phase 3 randomised controlled trial. BioDrugs. 2023;37(3):433–440. doi: 10.1007/s40259-023-00582-w
   PubMed Web of Science ®Google Scholar
• Bae SJ, Kim JH, Ahn SG, et al. Real-world clinical outcomes of biosimilar trastuzumab (CT-P6) in HER2-positive early-stage and metastatic breast cancer. Front Oncol. 2021;11:689587. doi: 10.3389/fonc.2021.689587
   PubMed Web of Science ®Google Scholar
• Bernat-Peguera A, Trigueros M, Ferrando-Diez A, et al. Efficacy of CT-P6 (trastuzumab biosimilar) versus reference trastuzumab in combination with pertuzumab in HER2-positive early-stage breast cancer: preclinical and real-life clinical data. Breast. 2022;62:1–9. doi: 10.1016/j.breast.2022.01.007
   PubMed Web of Science ®Google Scholar
• Park JH, Yeo JH, Kim YS, et al. Efficacy and safety of trastuzumab biosimilar (CT-P6) compared with reference trastuzumab in patients with HER2-positive advanced gastric cancer: a retrospective analysis. Am J Clin Oncol. 2022;45(2):61–65. doi: 10.1097/COC.0000000000000887
   PubMed Web of Science ®Google Scholar
• Dang A. Real-world evidence: a primer. Pharmaceut Med. 2023;37(1):25–36. doi: 10.1007/s40290-022-00456-6
   PubMed Web of Science ®Google Scholar
• Feltelius N, Gedeborg R, Holm L, et al. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective. Ups J Med Sci. 2017;122(2):136–147. doi: 10.1080/03009734.2017.1285837
   PubMed Web of Science ®Google Scholar
• Korean Ministry of Food and Drug Safety. Herzuma (trastuzumab): prescribing information [Korean] [Internet]. 2014 Jan 15 [cited 2023 Aug 18]. Available from: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=201400158aupdateTs2023-07-03%2017:55:00.0b
   Google Scholar
• National Institute of Diabetes and Digestive and Kidney Diseases. LiverTox: clinical and research information on drug-induced liver injury [internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2019. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548733/
   Google Scholar
• Mendes D, Abrantes J, Rigueiro G, et al. Real-world intensive safety monitoring of biosimilars rituximab and trastuzumab in a Portuguese oncology hospital. J Oncol Pharm Pract. 2021;27(6):1432–1438. doi: 10.1177/1078155220957079
   PubMed Web of Science ®Google Scholar
• Esteva FJ, Baranau YV, Baryash V, et al. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial. Cancer Chemother Pharmacol. 2019;84(4):839–847. doi: 10.1007/s00280-019-03920-4
   PubMed Web of Science ®Google Scholar
• Colomer R, Saura C, Sanchez-Rovira P, et al. Neoadjuvant management of early breast cancer: a clinical and investigational position statement. Oncology. 2019;24(5):603–611. doi: 10.1634/theoncologist.2018-0228
   Google Scholar
• Mazzotta M, Krasniqi E, Barchiesi G, et al. Long-term safety and real-world effectiveness of trastuzumab in breast cancer. J Clin Med. 2019;8(2):254. doi: 10.3390/jcm8020254
   PubMed Web of Science ®Google Scholar