Overview of monoclonal antibody biosimilars in Latin America

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This article describes the current situation of biosimilar monoclonal antibodies in 10 countries of Latin America and their potential to reduce the cost of antibody therapies.


In Latin America, over the last few years, the expiration of patents protecting therapeutic monoclonal antibodies opened a door for the development and approval of biosimilar versions of these drugs. Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, México, Paraguay, Perú and Uruguay all have biosimilar monoclonal antibodies approved.

The number of approved biological medicines in the global pharmaceutical market has considerably increased in recent decades. By 2021, it is estimated that 106 monoclonal antibodies would have been approved in the US or European Union for treatment of an expanding spectrum of diseases. This presents an opportunity for biopharmaceutical companies in Latin America to enter this market, encouraged also by their governments.

Biosimilar monoclonal antibodies are highly similar to reference monoclonal antibodies in terms of pharmaceutical quality, safety, and efficacy. Monoclonal antibodies are used to treat patients with chronic diseases such as cancer, rheumatoid arthritis and autoimmune disease.

By December 2021, there were in Latin America five therapeutic monoclonal antibodies approved whose patents expired in the last years and have biosimilar versions commercialized, see Table 1. These are rituximab, trastuzumab, infliximab, adalimumab and bevacizumab.  

Table 1: Overview of the number of monoclonal antibody biosimilars approved in Latin American countries [1]
Country Biosimilars approved
Rituximab Trastuzumab Infliximab Adalimumab Bevacizumab
Argentina X X X X X
Brazil X X X X X
Colombia X X X X X
Paraguay X X X   X
Peru X X X X  
Chile X X X    
Mexico X X X    
Bolivia   X      
Ecuador         X
Uruguay X        


Argentina and Brazil with more than 10 biosimilars approved are the countries with most biosimilar monoclonal antibodies approved. Then follow by countries like Colombia, Peru, Paraguay, Mexico and Chile, with 3 to 5 biosimilars of monoclonal antibodies, and other Latin American countries like Ecuador, Bolivia and Uruguay have the lowest adoption on biosimilar monoclonal antibodies [1].

The Latin American market for monoclonal antibodies is expected to experience a rapid growth in the coming years. Thus, more biosimilar monoclonal antibodies will increase competition, decreasing the healthcare costs and expanding their accessibility.

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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.

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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.

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1. Karp P, Gatto M, Batto MV, et al. Biosimilar monoclonal antibodies in Latin America. doi:http://dx.doi.org/10.5772/intechopen.101227

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