REFLECTIONS AND PERSPECTIVES ON BIOSIMILARS IN BRAZIL

RENATA LUZES ARAUJO; GABRIELA BITTENCOURT GONZALEZ MOSEGUI; CID MANSO D. E. MELLO VIANNA; FERNANDO ANTONANZAS VILLAR; THAIS PEREIRA CATAO

doi:10.22159/ijpps.2020v12i7.37903

Authors

RENATA LUZES ARAUJO Social Medicine Institute (Instituto de Medicina Social), Rio de Janeiro State University (Universidade do Estado do Rio de Janeiro–UERJ), Brazil
GABRIELA BITTENCOURT GONZALEZ MOSEGUI Community Health Institute (Instituto de Saude da Comunidade), Fluminense Federal University (Universidade Federal Fluminense UFF), Brazil https://orcid.org/0000-0001-5954-684X
CID MANSO D. E. MELLO VIANNA Social Medicine Institute (Instituto de Medicina Social), Rio de Janeiro State University (Universidade do Estado do Rio de Janeiro–UERJ), Brazil https://orcid.org/0000-0003-0252-1144
FERNANDO ANTONANZAS VILLAR Department of Economy and Company, Economy Faculty, University of La Rioja, Logrono, La Rioja, Spain https://orcid.org/0000-0001-6122-9130
THAIS PEREIRA CATAO Department of Economy and Company, Economy Faculty, University of La Rioja, Logrono, La Rioja, Spain https://orcid.org/0000-0002-2751-076X

DOI:

https://doi.org/10.22159/ijpps.2020v12i7.37903

Keywords:

Biological products, Drug price, Access to essential medicines, Health technologies

Abstract

Objective: Biological agents are among the medicines with the highest revenue in the world market. Biosimilars are copies of biological products introduced into the market to offer clinical efficacy like the originator or reference product at lower prices. This study aimed to verify the characteristics and price differences between biological medicines registered and marketed in Brazil until the end of 2019.

Methods: All records were collected by November 2019 on the website of the National Health Surveillance Agency (Anvisa). The list of the Chamber of Regulation of the Medicines Market (CMED) consulted for the price analysis, has an economic classificatory criterion with eight ranges. Categorization, according to the date/period of authorization for marketing, was also made.

Results: At Anvisa site, there are 144 drugs present in 277 products distributed in three regulatory categories: new, biological, and similar. Approximately 73% of drugs have been approved in the past five years. Three classes represent 77.9% of all drugs-antineoplastics and immunomodulatory agents (38.6%), blood and blood organ forming (20.7%), and alimentary tract and metabolism (18.6%). Of the 178 products listed in the CMED, 26 (14.6%) have prices above 10,000 reais.

Conclusion: The prices of original products, for most of the inputs, are lower than those of biosimilars, reversing the international logic.

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Author Biography

GABRIELA BITTENCOURT GONZALEZ MOSEGUI, Community Health Institute (Instituto de Saude da Comunidade), Fluminense Federal University (Universidade Federal Fluminense UFF), Brazil

Health and Society Department

Associate Professor

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