Preview

Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

Advanced search

Generics and biosimilars in oncology

Abstract

Cancer-related morbidity and mortality have been increasing worldwide including in Russia. In recent decades, many innovative antineoplastic pharma products have been launched in the international pharmaceutical market; however, their high price has resulted in significant increase in the cost of treatment and in its inaccessibility for a considerable percentage of patients not only in the countries experiencing low economic growth, but also in those with a high level of economic development. One of the most effective ways of reducing the cost of pharmacotherapy is replacement of innovation medications after the expiration of the patent with their generics and biosimilars. In this article the authors discuss the cost of oncopathology pharmacotherapy with original drugs and their generics and also the factors that affect cost-effectiveness of generics and biosimilars in oncology.

About the Authors

I. A. Gopienko
Peoples’ Friendship University of Russia, Medical Institute Russian Federation
Russian Federation
Gopienko Irina – Postgraduate at the Department of General and Clinical Pharmacology. SPIN code: 8192-4441


E. A. Ushkalova
Peoples’ Friendship University of Russia, Medical Institute Russian Federation
Russian Federation

Ushkalova Elena – MD, PhD, professor of the Department of General and Clinical Pharmacology. SPIN code: 7722-5802

 



S. K. Zyryanov
Peoples’ Friendship University of Russia, Medical Institute Russian Federation; State Budgetary Institution of the City of Moscow City Clinical Hospital No. 24 of the Moscow City Health Department Russian Federation
Russian Federation

Zyryanov Sergey – MD, professor, Head of Department of General and Clinical Pharmacology. SPIN code: 2725-9981

Moscow



References

1. Renner L, Nkansah FA, Dodoo AN. The role of generic medicines and biosimilars in oncology in low-income countries. Ann Oncol. 2013 Sep;24 Suppl 5:v29-32. DOI: 10.1093/annonc/mdt326/

2. Who.int [internet]. World Health Organization. Cancer [updated 12 September 2018; cited 2020 Jan 20]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.

3. Farmer P, Frenk J, Knaul FM, et al. Expansion of cancer care and control in countries of low and middle income: a call to action. Lancet. 2010;376:1186-93. DOI: 10.1016/S0140-6736(10)61152-X.

4. Jaffray DA, Gospodarowicz M. Bringing global access to radiation therapy: time for a change in approach. Int J Radiat Oncol Biol Phys. 2014;89(3):446-7. DOI: 10.1016/j.ijrobp.2014.05.019

5. Dagenais GR, Leong DP, Rangarajan S, et al. Variations in common diseases, hospital admissions, and deaths in middle-aged adults in 21 countries from five continents (PURE): a prospective cohort study. Lancet. 2019 Sep 3. DOI: 10.1016/S0140-6736(19)32007-0

6. Torre LA, Siegel RL, Ward EM, Jemal A. Global Cancer Incidence and Mortality Rates and Trends-An Update. Cancer Epidemiol Biomarkers Prev. 2016;25(1):16-27. DOI: 10.1158/1055-9965.EPI-15-0578

7. Zlokachestvennye novoobrazovaniya v Rossii v 2018 godu (zabolevaemost’ i smertnost’). Ed by Kaprin A.D., Starinskiy V.V., Petrova G.V. — Moscow: MNIOI im. P.A. Gertsena — filial FGBU «NMIRTs» Minzdrava Rossii; 2019. (In Russ).

8. 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;68(6):394-424. DOI: 10.3322/caac.21492

9. Rakfond.ru [internet]. Cancer statistics: incidence and mortality [updated 19.10.2018; cited 2020 Jan 20]. Available from: https://www.rakfond.org/en/2018/10/19/cancer-statistics-incidence-and-mortality.

10. Global Burden of Disease Cancer Collaboration, Fitzmaurice C, Dicker D, Pain A, et al. The Global Burden of Cancer 2013. JAMA Oncol. 2015;1(4):505-27. DOI: 10.1001/jamaoncol.2015.0735

11. Goss PE, Strasser-Weippl K, Lee-Bychkovsky BL, et al. Challenges to effective cancer control in China, India, and Russia. Lancet Oncol. 2014;15(5):489-538. DOI: 10.1016/S1470-2045(14)70029-4

12. Cancer.org [internet]. American Cancer Society. Global Cancer Facts and Figures (4rd Edition). American Cancer Society [updated 2018; cited 20Jan-2020]. Available from: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/globalcancer-facts-and-figures-4th-edition.pdf

13. Barchuk A, Bespalov A, Huhtala H, et al. Productivity losses associated with premature mortality due to cancer in Russia: A population-wide study covering 2001-2030. Scand J Public Health. 2019;47(5):482-491. DOI:10.1177/1403494819845565

14. Arnold M, Rutherford MJ, Bardot A, et al. Progress in cancer survival, mortality, and incidence in seven high-income countries 1995-2014 (ICBP SURVMARK-2): a population-based study. Lancet Oncol. 2019;20(11):14931505. DOI: 10.1016/S1470-2045(19)30456-5

15. Godman B, Hill A, Simoens S, et al. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(2):49-70. DOI: 10.5639/gabij.2019.0802.007

16. Savage P, Mahmoud S, Patel Y, Kantarjian H. Cancer Drugs: An International Comparison of Postlicensing Price Inflation. J Oncol Pract. 2017;13(6):e538-e542. DOI: 10.1200/JOP.2016.014431

17. Prasad V, Mailankody S. How should we assess the value of innovative drugs in oncology? Lessons from cost-effectiveness analyses. Blood. 2015;126:1860-1. DOI: 10.1182/blood-2015-07-657478

18. Medscape.com [internet]. Cancer Drugs Dominate Top 10 Best-Selling Drugs in 2018; Medscape [updated Mar 19, 2019; cited 2020 Jan 20]. Available from: https://www.medscape.com/viewarticle/910600.

19. Iqvia.com [internet]. IQVIA Institute for Human Data Science. Global Oncology Trends 2018: Innovation, Expansion and Disruption. [updated 2018; cited 2020 Jan 20]. Available from: https://www.iqvia.com/insights/theiqvia-institute/reports/global-oncology-trends-2018.

20. Evaluate.com [internet]. EvaluatePharma ® World Preview 2017, Outlook to 2022.10th Edition [updated June 2017; cited 2020 Jan 20]. Available from: https://www.evaluate.com/thought-leadership/pharma/evaluatepharmaworld-preview-2018-outlook-2024.

21. Biocad.ru [интернет]. Эксперты ожидают роста рынка онкологических препаратов в России в 2019 году минимум на 4% [доступ от 20.01.2020]. Доступ по ссылке https://biocad.ru/post/eksperty_ozhidayut_rosta_rynka_onkologicheskih_preparatov_v_rossii_v_2019_godu_minimum_na_4_.

22. Spencer JC, Samuel CA, Rosenstein DL, et al. Oncology navigators’ perceptions of cancer-related financial burden and financial assistance resources. Support Care Cancer. 2018;26(4):1315-1321. DOI: 10.1007/s00520017-3958-3

23. Bhoo-Pathy N, Ng CW, Lim GC, 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-e546. DOI: 10.1200/JOP.18.00619

24. 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):187-192. DOI: 10.1200/JOP.2017.027359

25. Choy E, Jacobs IA. Biosimilar safety considerations in clinical practice. Semin Oncol. 2014;41 Suppl 1:S3-14. DOI: 10.1053/j.seminoncol.2013.12.001

26. Researchandmarkets.com [internet]. IMARC Group. Oncology Biosimilars Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024 [updated October 2019; cited 2020 Jan 20]. Available from: https://www.researchandmarkets.com/reports/4856249/oncology-biosimilars-market-global-industry?utm_source=dynamic&utm_medium=CI&utm_code=qd93bc&utm_campaign=1330186+-+Global+Oncology+Biosimilars+Market+Insights+and+Outlook+to+2024+by+Drug+Type%2c+Cancer+Type%2c+Distribution+Channel+%26+Region&utm_exec=joca220cid.

27. Chto stoyat novye protivorakovye bioanalogi kompanii Biocad? (In Russ). [опубликовано 31.05.2016; доступ от 20.01.2020]. Доступ по ссылке https://versia.ru/chto-stoyat-novye-protivorakovyebioanalogi-kompanii-biocad.

28. Dolya otechestvennykh onkopreparatov na rossiiskom rynke dostigla 80% (In Russ). [опубликовано 15.06.2017; доступ от 20.01.2020]. Доступ по ссылке https://vademec.ru/news/2017/06/14/davydov-dolya-otechestvennykh-protivorakovykh-lekarstv-na-rossiyskomrynke-dostigla-80/.

29. Thill M, Thatcher N, Hanes V, Lyman GH. Biosimilars: what the oncologist should know. Future Oncol. 2019;15(10):1147-1165. DOI: 10.2217/fon-2018-0728

30. Global Oncology Trend Report: A Review of 2015 and Outlook to 2020 [updated June 2016; cited 2020 Jan 20]. Available from: https://morningconsult.com/wp-content/uploads/2016/06/IMS-Institute-GlobalOncology-Report-05.31.16.pdf.

31. Iqvia.com [internet]. IMS Institute for Health Informatics. Delivering on the potential of biosimilar medicines. Parsippany: IMS Institute for Health Informatics [updated 2016; cited 2020 Jan 20]. Available from: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/delivering-on-the-potentialof-biosimilar-medicines.pdf.

32. Asco.org [internet]. ASCO. American Society of Clinical Oncology Position Statement on Addressing the Affordability of Cancer Drugs. Published online July 19, 2017. [updated June 2016; cited 2020 Jan 20]. Available from: https://www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/documents/2017-ASCO-Position-Statement-Affordability-Cancer-Drugs.pdf?et_cid=39454952&et_rid=1760459169&linkid=position+statement.

33. Tabernero J, Vyas M, Giuliani R, et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017;1(6):e000142. DOI: 10.1136/esmoopen-2016-000142

34. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018 30;7(4):3.

35. Yang YT, Nagai S, Chen BK, et al. Generic oncology drugs: are they all safe? Lancet Oncol. 2016;17(11):e493-e501. DOI: 10.1016/S14702045(16)30384-9

36. Potts J, Genov G, Segec A, et al. Improving the Safety of Medicines in the European Union: From Signals to Action. Clin Pharmacol Ther. 2019 Oct 17. DOI: 10.1002/cpt.1678

37. Ingrasciotta Y, Cutroneo PM, Marcianò I, et al. Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction. Drug Saf. 2018;41(11):1013-1022. DOI: 10.1007/s40264-018-0684-9

38. Sagi S, Cohen HP, Woollett GR. Pharmacovigilance of Biologics in a Multisource Environment. J Manag Care Spec Pharm. 2017;23(12):1249-1254. DOI: 10.18553/jmcp.2017.23.12.1249

39. Baldo P, Fornasier G, Ciolfi L, et al. Pharmacovigilance in oncology. Int J Clin Pharm. 2018;40(4):832-841. DOI: 10.1007/s11096-018-0706-9

40. Schellekens H, Smolen JS, Dicato M, Rifkin RM. Safety and efficacy of biosimilars in oncology. Lancet Oncol. 2016;17(11):e502-e509. DOI: 10.1016/S1470-2045(16)30374-6

41. Vial J, Cohen M, Sassiat P, Thi?baut D. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis. Curr Med Res Opin. 2008;24(7):2019-33. DOI: 10.1185/03007990802207874

42. Medvestnik.ru [интернет]. Врачи онкоцентра Блохина сообщили министру о токсичности детских дженериков [опубликовано 20.12.2019; доступ от 20.01.2020]. Доступ по ссылке https://medvestnik.ru/content/news/Vrachi-onkocentra-Blohina-soobshili-ministru-o-toksichnosti-detskihdjenerikov.html.

43. Medvestnik.ru [интернет]. Онкологи Екатеринбурга сообщили в Росздравнадзор о побочных эффектах 19 детских дженериков противоопухолевых препаратов и лекарств сопроводительной терапии [опубликовано 24.12.2019; доступ от 20.01.2020]. Доступ по ссылке https://medvestnik.ru/content/news/Onkologi-Ekaterinburga-soobshili-vRoszdravnadzor-o-pobochnyh-effektah-19-detskih-djenerikov.html.

44. Fda.gov [internet]. Food and Drug Administration. Warning letters and notice of violation letters to pharmaceutical companies. [updated 2019 May 10; cited 2020 January 20]. Available from: https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letterspharmaceutical-companies.

45. Cheung WY, Kornelsen EA, Mittmann N, et al. The economic impact of the transition from branded to generic oncology drugs. Curr Oncol. 2019;26(2):89-93. DOI: 10.3747/co.26.4395

46. Greenberg D, Earle C, Fang CH, et al. When is Cancer Care Cost-Effective? A Systematic Overview of Cost—Utility Analyses in Oncology. J Natl Cancer Inst. 2010;102(2):82-8. DOI: 10.1093/jnci/djp472


Review

For citations:


Gopienko I.A., Ushkalova E.A., Zyryanov S.K. Generics and biosimilars in oncology. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2019;(4):15-22. (In Russ.)

Views: 829


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)