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.
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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