Follow-on biological/ biosimilar approvals in Latin America by therapeutic class

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Follow-on biological/ biosimilar approvals in Latin America by therapeutic class

Home/Reports | Posted 03/04/2024 0 Post your comment

According to a review by Machado et al., across seven Latin American nations, biosimilar approval patterns diverge from Canada, Europe, and the US. Anti-anaemic and diabetes treatments are notably lacking approvals, while Brazil emerges as a leader in biosimilar authorization [1].

The approval landscape of biosimilars in various therapeutic classes across seven Latin American countries show some differences compared to Canada, Europe and the US.

Table 1 presents the number of biosimilars approved by regulatory authority according to the ATC classification and the international nonproprietary name.

In the class of anti-anaemic preparations, only epoetin alfa has secured approval in Mexico. Epoetin lambda, epoetin zeta, and erythropoietin did not receive approval in any of the seven Latin American countries, while Europe and US have approved five and one anti-anaemic preparations, respectively.

Both Argentina and Colombia lack approved biosimilars for medications addressing diabetes, a prevalent lifestyle disease impacting a significant population.

The approval of somatropin and teriparatide biosimilars has only occurred in Brazil and Colombia, respectively, while Canada and Europe have approved 2 and 5 teriparatide biosimilars, respectively.

Additionally, there is an absence of approval for ophthalmological ranibizumab biosimilar in the seven Latin American countries, while Canada, Europe and the US have approved 1, 3 and 2, respectively. Two ranibizumab biosimilars (Byooviz (ranibizumab-runa) and Cimerli (ranibizumab-eqrn)) received interchangeable designation in the US.

By May 2023, Brazil has 52 registered biosimilar medicines and approximately 30 products awaiting analysis or already being analysed by ANVISA [2]. This indicates that Brazilian biosimilar approvals have surpassed those of the US FDA, which has approved 47 biosimilars by March 2024 [3], placing Brazil in second position globally for biosimilar approvals, behind only the European Medicines Agency.

First approvals of similar biotherapeutics in seven Latin American countries

Follow-on biological/biosimilar approvals landscape 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 the latest headline article: Cuestionando la necesidad de evaluaciones de sensibilidad étnica para anticuerpos monoclonales biosimilares

Browse the news in the Latin American Forum!

FORO LATINOAMERICANO
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.

Ver el último artículo de cabecera: Cuestionando la necesidad de evaluaciones de sensibilidad étnica para anticuerpos monoclonales biosimilares

!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.

References
1. Machado FLDS, Cañás M, Doubova SV, Urtasun MA, Marín GH, Osorio-de-Castro CGS, et al. Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison. Regul Toxicol Pharmacol. 2023 Sep 1;144:105485. doi: 10.1016/j.yrtph.2023.105485.
2. Cestari de Oliveira SH. Follow-on biologicals/biosimilars approved in Brazil: May 2024 update. Generics Biosimilars Initiative Journal. (GaBI Journal). 2023;12(2):67-72. doi:10.5639/gabij.2023.1202.012

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