Brazil is a country active in life sciences research, publications, manufacturing and exports. Biosimilars have the highest growth potential for the pharmaceutical sector in Latin America .
While they are pricier to produce, they feature higher sale prices than generics, with their attractiveness coming from being cheaper than the originator products they compete with. Nevertheless, the growth of this segment also encounters institutional barriers. Pharmaceutical companies may try to hold off biosimilars by extending intellectual property right protection, whereas the medical profession may resist their use on the grounds that they are not close enough in terms of efficacy and safety. Brazil is considered as well one of the countries in Central America who leads in the use of biosimilars .
New drugs have the largest share of the pharmaceutical market in Brazil while biological drugs were the ones that grew .
The regulatory framework for the authorization/registration of biosimilar medicines/biological products in Brazil are ANVISA’s Resolution RDC No. 55 of 16 December 2010 (Resolution No. 55/2010) and Resolution RDC No 49 of 29 September 2011 .
The first biosimilar for trastuzumab was approved by the European Medicines Agency (EMA) in 2017 . Currently, there are seven trastuzumab biosimilars available to countries in Latin America and the Caribbean. Brazil’s local companies, such as Libbs and Biomm are supplying trastuzumab biosimilars.
Domestic companies are more sheltered from international competition in Brazil and Argentina , resulting in a greater availability of cheaper originator products, but also in more expensive generics.
Some of the most important domestic pharmaceutical companies in Brazil are shown in Table 1.
| Table 1: Top domestic pharmaceutical companies in Brazil
| Pharma company
|| Exporting countries
|| Generics and branded generics
– Other countries in LA
– Western Europe
|| Generics, branded generics, and plant-based medicines
– Other countries in LA
|| Generics and branded generics pharmaceuticals
|| – Other countries of LA
(partnership between the Brazilian government with Aché, EMS, Hypermarcas, and União Química)
– Other countries in LA
– Eastern Europe
| LA: Latin America.
This article discusses the study results of pharmaceuticals development in other countries of Latin America and the Caribbean covering Argentina, Brazil, Chile, Colombia, Mexico, Costa Rica and Cuba.
Pharmaceutical manufacturing companies in Argentina
Brazilian market of biosimilars
Market outlook for biological medicines in Brazil 2016-2025
Pharmaceutical market of biological and biosimilar medicines in Brazil
Regulatory landscape for similar biotherapeutic products in Latin America
LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View this week’s headline article: Acceso a biosimilares para tratamientos contra el cáncer en América Latina
Browse the news in the Latin American Forum!
Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Vea el artículo principal de esta semana: Acceso a biosimilares para tratamientos contra el cáncer en América Latina
!Explore las noticias en el Foro Latinoamericano!
Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
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2. Vargas V, Rama M, Singh R. Pharmaceuticals in Latin America and the Caribbean players, access, and innovation across diverse models. 3 January 2022. World Bank. Available from: https://openknowledge.worldbank.org/handle/10986/36871 License: CC BY 3.0 IGO.
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
5. GaBI Online - Generics and Biosimilars Initiative. Pharmaceutical market of biological and biosimilar medicines in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/reports/pharmaceutical-market-of-biological-and-biosimilar-medicines-in-brazil
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