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 biosimilars. In 2005, these regulations were revised, however, no alternate pathway for biosimilars was specified and a full dossier was still required.
Brazil has now introduced new regulations to address and establish specific pathways to license biosimilars. 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 biosimilars:
This guideline covers all biosimilars:
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 biosimilars: a comparative pathway and an individual development pathway. In the individual development pathway, a reduced dossier can be presented. The applicant needs to present complete data regarding quality issues but it does not have to be comparative.