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 presents the regulatory landscape for SBP in Latin America.  

  
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.

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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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