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.
GaBI Journal Citation Impact
2.2 – CiteScore 2021 (calculated on 5 May 2022)
2.3 – CiteScoreTracker 2021 (Last updated on 6 June 2022)
Submit a manuscript to GaBI Journal
Related articles
Nomenclature of biologicals and biosimilars in Peru
Biosimilars approved in Argentina
Biosimilars approved in Chile
Biosimilars approved in Brazil
| 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: El impacto de las insulinas biosimilares en el gasto público brasileño 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. LATIN AMERICAN FORUM 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: El impacto de las insulinas biosimilares en el gasto público brasileño !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.
|
Reference
1. Karp P, Gatto M, Batto MV, et al. Biosimilar monoclonal antibodies in Latin America. doi:http://dx.doi.org/10.5772/intechopen.101227
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.
0
Post your comment