Análise crítica da legislação para registro de Produtos Biológicos/Biossimilares em quatro países latino-americanos nos aspectos de extrapolação da indicação, estudos comparativos, intercambialidade e farmacovigilância face às diretrizes da Organização Mundial da Saúde

• Autor(a) principal: Maioli, Maria Angélica Paixão
• Data de Publicação: 2014
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Biblioteca Digital de Teses e Dissertações da UERJ
• Texto Completo: http://www.bdtd.uerj.br/handle/1/15029
• topic: Biosimilar pharmaceuticals; Health care regulation and monitoring; Latin America; Medicamentos biossimilares; Regulação e fiscalização em saúde; América Latina; Medicamentos - Biodisponibilidade; Medicamentos genéricos - Brasil; Medicamentos genéricos - Legislação - Brasil; Medicamentos - Patentes - Brasil; Organização Mundial da Saúde - Regulamentação; CNPQ::CIENCIAS DA SAUDE

Biological products (BPs) have a history of success in treating many chronic diseases with high morbidity and mortality. However, their high cost is a limiting factor for access to the vast majority of patients. Recently, the expiration of patents of the first large group of biological reference products (BRPs) fostered the production of biological drugs that are meant to be similar to an original licensed product which the World Health Organization (WHO) has named similar biotherapeutical products (SBPs). These products depend in part on prior information on the safety and efficacy data obtained with BRPs, to be registered by the national regulatory authority (NRA). Clinical experience and safety profile of BRPs already known shall contribute to the development of PBSs. PBs are formed by relatively large protein complex and difficult to characterize. The term generics, therefore, is not suitable to describe them, because it applies to drugs of chemical origin with small molecules, which are structurally and therapeutically equivalent to an original drug that lost patent protection. The clinical performance of PBSs is greatly influenced by the manufacturing process, comparative studies are needed to prove their safety and efficacy. The NRAs from several countries have developed specific regulations on the requirements for registration of PBSs.The regulations should be harmonized with guidelines of standard-setting world bodies like WHO, in order to maintain safety and efficacy to their users. In this study a critical analysis of the licensing regulation for SBPs in Argentina, Brazil, Colombia and Mexico was performed, having the WHO guidelines as the gold standard, in relation to extrapolation of indication, comparative clinical and non-clinical studies, pharmacovigilance and interchangeability, this being in accordance with the American NRA. Through literature searches and on official websites, regulations of those countries and the WHO guidelines were raised. Each item was compared among selected countries and the first three items mentioned above, compared to those recommended by the WHO. Later, a critical analysis of the findings was performed. It was concluded that the regulations of Argentina, Brazil and Mexico have many points in common with the WHO guidelines, but all of them still need complementation to ensure uniformity in the development of each type of SBPs, as guides for non- clinical and clinical studies. The Brazilian NRA already has two of them. Colombia lacks standardization for numerous requirements for medicines. This kind of study must be performed continuously since the regulations are constantly changing