Regulatory landscape for similar biotherapeutic products in Latin America

Biosimilars/Research | Posted 09/07/2021 post-comment0 Post your comment

Most Latin American countries are in the process of or have already established their own regulatory guidelines for similar biotherapeutic products (SBPs), and there are regional recommendations on how to ensure the safety and efficacy of biosimilars.

Regulation V13H16

According to the authors [1], despite having the framework in place, national guidelines on interchangeability and naming are still lacking, and pharmacovigilance systems are very bureaucratic and perceived by many physicians to be far from clinical practice.

Table 1 presents the regulatory landscape for SBP in Latin America.  

Table 1: Regulatory landscape for similar biotherapeutic products in Latin America
Regulations in place Country Year
Argentina 2011/2012
Brazil 2010
Chile 2014
Colombia 2014
Costa Rica 2012
Cuba 2011
Ecuador 2013
Guatemala 2011
Mexico 2014
Panama 2008
Peru 2016
Dominican Republic 2017
Uruguay 2015
Regulations released Paraguay 2016
Regulations in preparation Bolivia  
Regulations in preparation Venezuela  

  

Table 1 presents the regulatory landscape for SBP in Latin America.  

Table 1: Regulatory landscape for similar biotherapeutic products in Latin America
Regulations in place Country Year
  Argentina 2011/2012
  Brazil 2010
  Chile 2014
  Colombia 2014
  Costa Rica 2012
  Cuba 2011
  Ecuador 2013
  Guatemala 2011
  Mexico 2014
  Panama 2008
  Peru 2016
  Dominican Republic 2017
  Uruguay 2015
Regulations released Paraguay 2016
Regulations in preparation Bolivia  
Regulations in preparation Venezuela  

  
The regulatory process for SBP should be harmonized according to the World Health Organization’s (WHO) recommendations in all Latin American countries. As more SBP become available, post-marketing assessment is essential to enable risk monitoring.

Ultimately, clinicians in Latin America need to be well informed about the principles of biosimilarity and the regulatory pathways adopted in their countries, as well as what they should expect in terms of the clinical characteristics of approved biosimilars.

Editor’s comment
Readers interested to learn more about similar biotherapeutic products in other countries are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Regulations for biotherapeutics approval in Colombia

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Reference
1. Azevedo VF, Babini A, Caballero-Uribe CV, et al. Practical guidance on biosimilars, with a focus on Latin America. What do rheumatologists need to know?.J Clin Rheumat. 2019;25:91-100. doi: 10.1097/RHU.0000000000000881

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