Journal of Health and Medical Sciences
ISSN 2622-7258
Published: 31 March 2024
Advancing Biosimilars in Latin America: A Comprehensive Analysis of Regulatory Frameworks, Market Trends, and Future Perspectives
Mike Rizo, Juan Velazquez
Pharmcare Services
Download Full-Text Pdf
10.31014/aior.1994.07.01.312
Pages: 114-120
Keywords: Biosimilars, Latin America, Regulatory
Abstract
Introduction: With the struggle to find cost-effective therapeutic options, there has been increased market interest for biosimilars in the Latin American region. This paper presents an in-depth exploration of the biosimilar landscape in Latin America. Methods: Key recommendations from the “Recommendations for the regulation of biosimilars and their implementation in Latin America,” as published in the Generics and Biosimilars Initiative Journal in 2014, were synthesized and integrated into insights from various reputable sources. Results: A nuanced perspective on the regulatory landscapes, market dynamics, and the challenges and opportunities that define the biosimilar ecosystem in Latin America. Discussion: There are persistent challenges in the Latin America, including physician and patient acceptance, pharmacovigilance, and the need for continuous education. However, there are several potential opportunities for growth and development within the region. Conclusion: Latin American countries would benefit from banding together to form an organization that allows all to contribute and benefit from relationships formed naturally by common geography, language, and goals
References
Azevedo, V. F., Mysler, E., Álvarez, A. A., Hughes, J., Flores-Murrieta, F. J., & Ruiz de Castilla, E. M. (2014). Recommendations for the regulation of biosimilars and their implementation in Latin America. Generics and Biosimilars Initiative Journal, 3(3), 143–148. https://doi.org/10.5639/gabij.2014.0303.032
Generics and Biosimilars Initiative. (2013, October 25). Similar biotherapeutic products approved and marketed in Latin America. GABI Online. https://www.gabionline.net/biosimilars/general/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
Ortiz-Prado, E., Ponce-Zea, J., Vasconez, J. E., Castillo, D., Checa-Jaramilloz, D. C., Rodríguez-Burneo, N., Andrade, F., Intriago- Baldeón, D. P., & Galarza-Maldonado, C. (2020). Current trends for biosimilars in the Latin American market. Generics and Biosimilars Initiative Journal, 9(2), 64–74. https://doi.org/10.5639/gabij.2020.0902.011
Pfizer. (2019, May 28). How access to biosimilar drugs could boost healthcare equity. https://www.pfizer.com/news/articles/how_access_to_biosimilar_drugs_could_boost_healthcare_equity
RAPS. (2023). Latin America Roundup – Brazil. https://www.raps.org/News-and-Articles/News-Articles/2023/10/Latin-America-Roundup-Brazil
Sandorff, E., Pinheiro, A. V., Bruni, D. S., Halbert, R. J., & Azevedo, V. F. (2015). Payer and physician evidence and discount requirements for biosimilars in three Latin American countries. Generics and Biosimilars Initiative Journal, 4(1), 11–16. https://doi.org/10.5639/gabij.2015.0401.005
The World Bank. (2024). GDP per capita (current US$). https://data.worldbank.org/indicator/%20NY.GDP.PCAP.CD
World Population Review. (2024). First world countries 2024. https://worldpopulationreview.com/country-rankings/first-world-countries