Last update: 15 March 2019
The regulatory body for approval of medicines in Brazil is the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which was created by Law 9782, enacted in 1999. ANVISA is responsible, under the authority of the Ministry of Health–Mínistério de Saúde–of the Brazilian Government, for drug registration and licences to pharmaceutical laboratories and to other companies inside the pharmaceutical production flow. The agency is also responsible for establishing regulations applicable to clinical trials and drug pricing, which is carried out by the Chamber of Drug Market Regulation.
Up until 2002, Brazil had no specific guidance for biological products. In 2002, however, guidelines for biological products were published (RDC 80/2002), which had to be followed by both originator biologicals and ‘follow-on biological products’ as they are called in Brazil. In 2005, these regulations were revised, however, no alternate pathway for follow-on biological products was specified and a full dossier was still required.
In December 2010, Brazil introduced new regulations to specifically address and establish specific pathways to license follow-on biological products. The Brazilian regulations (Resolution no. 55/2010) are based on different regulations and guidelines from around the world, including the WHO Similar Biological Product Guidelines. They follow the same scientific principles as the WHO guidelines but contain some differences due to the specific needs of Brazil.
Concepts in the Brazilian guidelines that are common with the WHO guidelines include: use of a reference biological product based on a suitable period of market use and the demonstration of sufficient scientific information on quality, efficacy and safety, as well as the need for specific pharmacovigillance.
ANVISA has the following guideline regarding follow-on biological products:
This guideline covers all follow-on biological products:
Resolução RDC n° 55 de 16 de dezembro de 2010. Dispões sobre o registro de produtos biológicos novos e produtos biológicos e da outras providências
Date: 16 December 2010
The guideline provides two regulatory pathways for follow-on biological products: a comparative pathway and an individual development pathway. This individual development pathway introduces a more permissive approach in which the copy product does not require a full comparison with the original one and a reduced dossier can be presented. The applicant needs to present complete data regarding quality issues but it does not have to be comparative . Therefore, this alternative pathway might approve products with an unknown degree of dissimilarity .
In Brazil, there is no system to designate non-proprietary names for active ingredients and there are no regulations for interchangeability of indications.
It should be noted, however,that follow-on biological products approved in Brazil may not have been authorized following as strict a regulatory process as is required for biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
EU guidelines for biosimilars
Global guidelines for biosimilars
1. Castanheira LG, et al. Current development in regulation of similar biotherapeutic products in Brazil. Biologicals 2011;39(5):308–11.
2. GaBI Online - Generics and Biosimilars Initiative. Comparison of Brazilian regulations for follow-on biologicals with the EMA, FDA and WHO [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 15]. Available from: www.gabionline.net/Biosimilars/Research/Comparison-of-Brazilian-regulations-for-follow-on-biologicals-with-EMA-FDA-and-WHO
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