BIOSIMILAR MEDICINE PRICE ANALYSIS IN BRAZIL: THE ANTIRHEUMATIC CASE

  • GABRIELA BITTENCOURT GONZALEZ MOSEGUI Community Health Institute, Fluminense Federal University, Rio de Janeiro, Brazil.
  • FERNANDO ANTOÑANZAS VILLAR Department of Economy and Company, Economy Faculty, University of La Rioja, Logroño, La Rioja, Spain. https://orcid.org/0000-0001-6122-9130
  • CID MANSO DE MELLO VIANNA Social Medicine Institute, Rio de Janeiro State University, Rio de Janeiro, Brazil. https://orcid.org/0000-0003-0252-1144
  • PAULA GARCIA ROJAS 2Department of Economy and Company, Economy Faculty, University of La Rioja, Logroño, La Rioja, Spain. https://orcid.org/0000-0003-4212-5445

Abstract

Objective: The introduction of biosimilar medicines in markets can bring savings to health systems, expanding the population’s access to various treatments. This study aims to analyze the price competition of biological agents and their biosimilars in Brazil within the scope of rheumatoid arthritis.


Methods: Prices for 14 presentations of original and biosimilar medicines were analyzed from January 2003 to October 2019 in Brazil. Prices were taken from official lists and were noted since launch and during the later trading period. Prices were converted to United States dollars and adjusted for inflation for the 2003 base year.


Results: In Brazil, during this review period, prices of biopharmaceuticals decreased in real values, reaching up to a 50% reduction. The introduction of biosimilars did not affect the price sharing of biological medicines.


Conclusion: Biosimilar antirheumatics do not yet have a significant impact on the price of biologics marketed in Brazil. A change in this scenario is expected in the medium and long term.

Keywords: Biological products, Drug price, Antirheumatic agents, Access to essential medicines, Health technologies

Author Biographies

GABRIELA BITTENCOURT GONZALEZ MOSEGUI, Community Health Institute, Fluminense Federal University, Rio de Janeiro, Brazil.

Health and Society Department

Associate Professor 

FERNANDO ANTOÑANZAS VILLAR, Department of Economy and Company, Economy Faculty, University of La Rioja, Logroño, La Rioja, Spain.

Department of Economy and Company, Economy Faculty, University of La Rioja, Logroño, La Rioja, Spain

CID MANSO DE MELLO VIANNA, Social Medicine Institute, Rio de Janeiro State University, Rio de Janeiro, Brazil.

Social Medicine Institute (Instituto de Medicina Social), Rio de Janeiro State University (Universidade do Estado do Rio de Janeiro – UERJ); Brazil

PAULA GARCIA ROJAS, 2Department of Economy and Company, Economy Faculty, University of La Rioja, Logroño, La Rioja, Spain.

Department of Economy and Company, Economy Faculty, University of La Rioja, Logroño, La Rioja, Spain

References

1. Castañeda-Hernández G, Szekanecz Z, Mysler E, Azevedo VF, Guzman R, Gutierrez M, et al. Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies. Joint Bone Spine 2014;81:471-7.
2. Ministry of Health (Brazil), National Health Surveillance Agency (Anvisa). Biological Medicines for the Treatment of Rheumatoid Arthritis. Executive Secretary. Brazil: National Health Surveillance Agency; 2012.
3. Ministry of Health (Brazil), National Health Surveillance Agency. Statistical Yearbook of the Pharmaceutical Market. Brazil: National Health Surveillance Agency; 2018. Available from: http://www.portal.anvisa.gov.br/documents/374947/3413536/ Anu%C3%A1rio+Estat%C3%ADstico+do+Mercado+Farmac%C3%A Autico+-+2018/c24aacbf-4d0c-46a7-bb86-b92c170c83e1.
4. Zozaya N, Pérez-Camarero S, Martínez-Galdeano L. La Regulación y Financiación de los Medicamentos Biosimilares en la OCDE; 2017. Available from: http://www.weber.org.es/wp-content/uploads/2018/04/ La_Regulacion_y_financiacion_de_los-biosimilares_en_la-OCDE_ weber.pdf.
5. González A, Ivanova Y, Zozaya N, Jiménez M, Hidalgo Á. The Introduction of Biosimilars in Spain. Estimation of Time for the National Health System. Madrid: Primera; 2017. p. 33. Available from: http://www.weber.org.es/wp-content/uploads/2018/04/Introducción-de-los-Biosimilares-en-España.pdf.
6. Malipatil NB, Haridas K, Prithvi SD. An overview of biosimilars. Asian J Pharm Clin Res 2015;8:23-7.
7. Bernal-Camargo DR, Gaitán-Bohórquez JC, León-Robayo ÉI. Biosimilar medicines in Colombia: An approach from the informed consumption. Rev Cienc Salud 2018;16:311-39.
8. Rovira J, Espín J, García L, Labry AO. The Impact of Biosimilars’ Entry in the EU Market; 2011. Available from: http://www.citeseerx.ist.psu. edu/viewdoc/citations;jsessionid=3D0987A4E2161E07E773A301041 639E4?doi=10.1.1.357.2218.
9. Levenhagen K, Davies C, Perdomo M, Ryans K, Gilchrist L. Clinical Practice Guideline. New York: United Rheumatology; 2019.
10. Biosimilars Review and Report. Biosimilars, Biologics, FDA Policy and Approvals, Clinical Trials, and Specialty Pharmacy; 2019. Available from: https://www.biosimilarsrr.com/biosimilars-reviews-reports.
11. Drug Price Finder; 2019. Available from: https://www.drugs.com.
12. Mysler E, Álvarez AA, Hughes J, Flores-Murrieta FJ. Recommendations for the regulation of biosimilars and their implementation in Latin America. Generics Biosimilars Initiat J 2014;3:143-8.
13. Institute of Health Policy Studies. High Cost Drugs 403 for More Expensive Costs in Argentina than in the United Kingdom; 2016. Available from: http://www.ieps.com.ar/es/template. php?file=notas/2016/08/16-08-31_Medicamentos-de-alto-costo-403- por-ciento.html.
14. Gomes EB, Rosseto R, Pinheiro L, Hasenclever L, Paranhos J. Development of biosimilars in Brazil. Front J Soc Technol Environ Sci 2016;5:31. Available from: http://www.revistas.unievangelica.edu.br/ index.php/fronteiras/article/view/1628.
15. Garcia R, Araujo DV. The regulation of biosimilars in Latin America. Curr Rheumatol Rep 2016;18:16.
16. Ministry of Health (Brazil), National Health Surveillance Agency. Consultation of the Medication Registry; 2019. Available from: http:// www.portal.anvisa.gov.br/consulta-produtos-registrados.
17. Ministry of Health, Health Assistance Secretariat (SAS). Clinical Protocol and Therapeutic Guidelines Rheumatoid Arthritis. Brazil: Ministry of Health; 2014. Available from: http://www.conitec.gov. br/images/Consultas/Relatorios/2019/Relatrio_PCDT_Artrite_ Reumatoide_CP21_2019.pdf.
18. Ministry of Health (Brazil), National Health Surveillance Agency (Anvisa). Consultation on the Price of Medicines Anvisa; 2019. Available from: http://www.portal.anvisa.gov.br/consulta-lista-de-preco-de-medicamento.
19. Brazilian Institute of Geography and Statistics-IBGE. Prices and Costs. Available from: https://www.ibge.gov.br/estatisticas/economicas/ precos-e-custos.html. [Last accessed on 2019 Nov 08].
20. Brazilian Central Bank. Currency and Exchange Converter; 2019. Available from: https://www.bcb.gov.br/conversao.
21. Health Care Secretariat. Clinical Protocol and Therapeutic Guidelines for Rheumatoid Arthritis. Public Consultation No. 21. Brazil: Official Gazette (DOU); 2019. p. 27.
22. Araujo DV. Drug Prices in Latin America: Challenges for Setting the Reference Price in the Region. Case Study. Brazil: Mercosul; 2015. p. 86-90.
23. Vieira FS, Zucchi P. Price differences between generic and innovator medicines in Brazil. Rev Saude Publica 2006;40:444-9.
24. McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs 2011;3:212-20.
25. BOE Technology Group. Urgent Measures to Guarantee the Sustainability of the National Health System and Improve the Quality and Safety of its Services. Royal Decree Law 16/2012. BOE Num 98. Spain: BOE Technology Group; 2012. Available from: https://www. boe.es/eli/es/rdl/2012/04/20/16.
26. Calo-Fernández B, Martínez-Hurtado JL. Biosimilars: Company strategies to capture value from the biologics market. Pharmaceuticals (Basel) 2012;5:1393-408.
27. Shaik R, Muragundi PM. Evaluation of price disparity among generic medicines in India. Asian J Pharm Clin Res 2018;11:466-8.
28. Interfarma. Understanding Biological Medicines Interfarma Assoc da Indústria Farm Pesqui. Brazil: Interfarma; 2012. Available from: https:// www.interfarma.org.br/public/files/biblioteca/34-biologicos-site.pdf.
29. Blackstone EA, Fuhr JP. Innovation and competition: Will biosimilars succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety. Biotechnol Healthc 2012;9:24-7.
30. Ministry of Health (Brazil), National Health Surveillance Agency (Anvisa). Generics and Similars Occupy 65% of the National Market Anvisa; 2019. Available from: http://www.portal.anvisa.gov.br/ noticias/-/asset_publisher/FXrpx9qY7FbU/content/genericos-e-similares-ocupam-65-do-mercado-nacional/219201. [Last accesssed on 2019 Nov 01].
Statistics
25 Views | 28 Downloads
Citatons
How to Cite
GONZALEZ MOSEGUI, G. B., F. A. VILLAR, C. M. D. M. VIANNA, and P. GARCIA ROJAS. “BIOSIMILAR MEDICINE PRICE ANALYSIS IN BRAZIL: THE ANTIRHEUMATIC CASE”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 9, June 2020, pp. 170-3, doi:10.22159/ajpcr.2020.v13i9.38641.
Section
Original Article(s)