Biosimilars in the practice of modern oncologist
https://doi.org/10.17650/1726-9776-2023-19-4-176-188
Abstract
Currently, genetically engineered drugs are widely used in oncological clinical practice which has significantly increased treatment cost. One of the most effective ways to decrease cost is substitution of an innovative drug after patent expiration with a reproduced compound – biosimilar.
In this article, a problem of biosimilars is actualized both worldwide and in Russia, characteristics of these products are described, and the path of the agents from the moment of reproduction through preclinical and clinical trials to introduction into real clinical practice is traced, examples of such trials are presented.
The results of clinical trials of effectiveness and safety of Pembroria® in patients with various oncological pathologies are described in detail. The first data from the multicenter prospective post-marketing trial PERFECTION are presented demonstrating similar effectiveness and tolerability results for the biosimilar in a multicohort patient category compared to pembrolizumab molecule.
Manufacturing of high-quality analogs and their introduction into clinical practice create a possibility to provide more patients in need with modern highly effective and safe drugs as well as increases effectiveness of the state healthcare system.
About the Authors
I. M. Shevchuk
N.A. Lopatkin Research Institute of Urology and Interventional Radiology – branch of the National Medical Research Radiological Center, Ministry of Health of Russia;
Medical Institute of Continuing Education, Russian Biotechnological University
Russian Federation
Russian Federation
Irina M. Shevchuk
Build. 1, 51 3rd Parkovaya St., Moscow 105425,
11 Volokolamskoe Shosse, Moscow 125080
A. S. Kalpinskiy
P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia
Russian Federation
Russian Federation
3 2nd Botkinskiy Proezd, Moscow 125284
References
1. Godman B., Hill A., Simoens S. et al. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Gen Biosimil Init J 2019;8(2):49–70. DOI: 10.5639/gabij.2019.0802.00718
2. Medscape.com [internet]. Cancer Drugs Dominate Top 10 BestSelling Drugs in 2018. Available at: https://www.medscape.com/viewarticle/910600.
3. Savage P., Mahmoud S., Patel Y., Kantarjian H. Cancer drugs: an international comparison of postlicensing price inflation. J Oncol Pract 2017;13(6):e538–42. DOI: 10.1200/JOP.2016.014431
4. Prasad V., Mailankody S. How should we assess the value of innovative drugs in oncology? Lessons from cost-eff ectiveness analyses. Blood 2015;126:1860–1. DOI: 10.1182/blood-2015-07-657478
5. IQVIA Institute for Human Data Science. Global Oncology Trends 2018: Innovation, Expansion and Disruption. Iqvia.com [internet]. Available at: https://www.iqvia.com/insights/theiqvia-institute/reports/global-oncology-trends-2018.
6. Spencer J.C., Samuel C.A., Rosenstein D.L. et al. Oncology navigators’ perceptions of cancer-related financial burden and financial assistance resources. Support Care Cancer 2018;26(4):1315–21. DOI: 10.1007/s00520-017-3958-3
7. Bhoo-Pathy N., Ng C.W., Lim G.C. et al. Financial toxicity after cancer in a setting with universal health coverage: a call for urgent action. J Oncol Pract 2019;15(6):e537–46. DOI: 10.1200/JOP.18.00619
8. American Society of Clinical Oncology. American Society of Clinical Oncology position statement on addressing the affordability of cancer drugs. J Oncol Pract 2018;14(3):187–92. DOI: 10.1200/JOP.2017.027359
9. Choy E., Jacobs I.A. Biosimilar safety considerations in clinical practice. Semin Oncol 2014;41 Suppl 1:S3–14. DOI: 10.1053/j.seminoncol.2013.12.001
10. Family identity: what is the difference between generics and biosimilars and how is the degree of their relationship to the original drugs determined. Vademecum. Available at: https://vademec.ru/article/semeynoe_tozhdestvo-_v_chem_raznitsa_mezhdu_dzhenerikami_i_bioanalogami_i_kak_opredelyaetsya_stepen%3Ferid%3DLdtCK6g18/?ysclid=lk81aqgdlm8310847. (In Russ.).
11. Gopienko I.A., Ushkalova E.A., Zyryanov S.K. Reproduced medications in oncology. Kachestvennaya klinicheskaya praktika = Good Clinical Practice 2019;(4):15–22. (In Russ.). DOI: 10.1016/2588-0519-2019-4-15-22
12. https://www.igbamedicines.org/doc/20220808_Module6.pdf.
13. Global Oncology Trend Report: A Review of 2015 and Outlook to 2020. Available at: https://morningconsult.com/wp-content/uploads/2016/06/IMS-Institute-GlobalOncology-Report-05.31.16.pdf.
14. ASCO. American Society of Clinical Oncology Position Statement on Addressing the Affordability of Cancer Drugs. Asco.org [Internet]. Available at: https://www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/documents/2017-ASCO-PositionStatement-Affordability-Cancer/
15. McCamish M., Woollett G. Worldwide experience with biosimilar development. MAbs 2011;3(2):209–17. DOI: 10.4161/mabs.3.2.15005
16. Perez E.A., Romond E.H., Suman V.J. et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol 2014;32(33):3744–52. DOI: 10.1200/JCO.2014.55.5730
17. Piccart-Gebhart M.J., Procter M., Leyland-Jones B. et al. Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353(16):1659–72.
18. Slamon D., Eiermann W., Robert N. et al. Breast Cancer International Research Group. Adjuvant trastuzumab in HER2- positive breast cancer. N Engl J Med 2011;365(14):1273–83. DOI: 10.1056/NEJMoa0910383
19. Nurgaziyev M.A., Gulyayev A.E., Zhaugasheva S.K. et al. The evidence of pharmacoeconomic profitability and easibility of domestic trastuzumab biosimilar using in HER2-positive breast cancer. Meditsina i ekologiya = Medicinе and Ecology 2020;1(94):125–32. (In Russ.).
20. Association of Oncologists of Russia. Results of phase I Pembroria® CT (INPN: pembrolizumab, BIOCAD LLC) proving equivalent pharmacokinetics received positive reaction from the leading experts. Available at: https://oncology-association.ru/rezultaty-ki-ifazy-pembroria-mnn-pembrolizumab-ao-biokad-dokazavshieekvivalentnost-farmakokinetiki-poluchili-polozhitelnuyu-oczenkuvedushhih-ekspertov?ysclid=lkcoday3s0994158322. (In Russ.).
21. Fedyanin M.Yu., Snegovoy A.V., Breder V.V. et al. Toxicity associated with immune checkpoint inhibitors: analysis of immunerelated adverse events with a pembrolizumab biosimilar (Pembroria). Bezopasnost’ i risk farmakoterapii = Safety and Risk of Pharmacotherapy 2023;11(2):215–30. (In Russ.). DOI: 10.30895/2312-7821-2023-11-2-360
Review
For citations:
Shevchuk I.M., Kalpinskiy A.S. Biosimilars in the practice of modern oncologist. Cancer Urology. 2023;19(4):176-188. (In Russ.) https://doi.org/10.17650/1726-9776-2023-19-4-176-188
Views:
394
Email this article 