Regulations of the registration of biosimilars in Latin America

Biosimilars/Research | Posted 17/12/2021 post-comment0 Post your comment

In the review and comparison of biosimilar products performed in the nine Latin American countries, particularities were found regarding their definition, as some regulations do not include the term, affecting the biosimilarity exercise and clinical and non-clinical information. In addition, differences were also found in aspects of their use, such as extrapolation of indications and automatic substitution or interchangeability. As for its labelling, further research by health authorities is required [1].


Biosimilar products are an important element of the regulations concerning health registration. Table 1 shows the information requested in the regulations reviewed for the registration of biosimilars in Costa Rica, Cuba, Brazil, Chile, El Salvador, Guatemala, Honduras, Dominican Republic, and Panama. It includes the definition of biosimilar and the biosimilarity exercise; the request for clinical, non-clinical, and immunogenicity information; a pharmacovigilance programme; information specific to biosimilars such as the extrapolation of indications and interchangeability or automatic substitution; and aspects of the labelling of these drugs [1].

Table 1: Comparison of the information requested in the regulations for the health registration of biosimilars in nine countries in Latin America
Information on the biosimilar product Central American, Caribbean and South American countries
Definition of biosimilar In the legislation of all countries, except for Honduras and Panama, the definition of biosimilar was indicated, while Cuba is multisource biological product.
Definition of biosimilarity exercise Only Chile and Honduras do not mention this section in their regulations.
Clinical and non-clinical information

Regarding the preclinical and clinical information requested, Brazil, Chile, Costa Rica, Guatemala, El Salvador and Dominican Republic request all the information obtained through the comparative studies as an indispensable requirement of the biosimilarity exercise.

Brazil requests that the comparative studies are in phase III, being clinical phases I and II only for the innovative product. Non-clinical in vivo studies, pharmacokinetic and pharmacodynamic studies and pivotal studies of safety and clinical efficacy.

El Salvador requests clinical and non-clinical studies comparative with the reference biological drug.

Guatemala and Panama are requesting comparative clinical studies with the innovator product.

In the case of Cuba, clinical studies are required depending on the amount of information available on the product at the international level. In the case of non-clinical studies, the results of the quality module will be considered. In cases where there are differences between products, the non-clinical evaluation will explore their impact on safety and efficacy.

Honduras only requires results from phase III clinical trial, leaving information from previous phases out.

Immunogenicity Only El Salvador and Honduras do not request information on immunogenicity.
Extrapolation of indications Brazil, Chile and Dominican Republic allow this approval. Cuba evaluates on a case-by-case basis. Costa Rica, El Salvador, Guatemala, Honduras and Panama do not consider it.
Interchangeability or automatic substitution

In Brazil, automatic substitution is considered to be a matter of clinical practice and not a regulatory aspect.

The only countries where interchangeability is indicated are Chile and the Dominican Republic.

In the case of Chile, it is specified that this action is possible as long as it is carried out through a staggered, procedural process and under medical supervision.

Pharmacovigilance Honduras is the only country among those studied that does not request it.
General provisions on labelling

The regulations of the countries studied do not have information on the labelling of these particular products.

Costa Rica, Guatemala, El Salvador, Honduras and Panama use Central American Technical Regulation (RTCA), which is not specific for products of biological and/or biotechnological origin. This case is the same for Chile and Cuba.

On the contrary, in the Dominican Republic, the non-innovative biotechnological product may use the monograph of the innovative or reference drug in its entirety as if it was its own, and the information that it must contain is indicated. For Brazil, it is specified that the leaflet and the label of the primary and secondary packaging must be in accordance with the legislation in force. Additionally, a copy of the leaflet approved by the authority of the country of origin must be provided together with its official translation.


In order to assist policymakers and regulatory authorities, healthcare organizations such as the Americas Health Foundation teamed up with a group of experts to discuss the main issues related to the use of biosimilars in Latin America [2].

Although the trend is to increase regulatory standards for the health registration of biosimilars in Latin America, regulations vary considerably from one country to another.

Biosimilars in Latin America face numerous challenges that require greater attention on behalf of governments.

Editor’s comment
Readers interested to learn more about biosimilars in Latin American markets are invited to visit to view the following manuscript published in GaBI Journal:

Current trends for biosimilars in the Latin American market

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Readers interested in contributing a research or perspective paper in Spanish and/or English to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.

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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.

View this week’s headline article: Guía evaluación de comparabilidad de medicamentos biológicos en Colombia

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: Guía evaluación de comparabilidad de medicamentos biológicos en Colombia

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. 


1. Ramirez-Telles M, Mora-Roman Jose J, Fallas-Cartin M. Registro sanitario de medicamentos biológicos y biotecnológicos en América Latina. Ars Pharm. 2021;62(2):131-43.
2. Feijó Azevedo V, Mysler E, Aceituno Álvarez A. Recommendations for the regulation of biosimilars and their implementation in Latin America. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):143-8. doi:10.5639/gabij.2014.0303.032

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