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 [2].

New drugs have the largest share of the pharmaceutical market in Brazil while biological drugs were the ones that grew [3].

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 [4].
The first biosimilar for trastuzumab was approved by the European Medicines Agency (EMA) in 2017 [3]. 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 [5], 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.

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.

Related articles
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

References
1. GaBI Online - Generics and Biosimilars Initiative. Pharmaceutical companies in Latin America and the Caribbean [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/generics/general/pharmaceutical-companies-in-latin-america-and-the-caribbean
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.