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Biossimilares do interferão : vantagens e problemas
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Autores
Orientador(es)
Resumo(s)
A expiração de patentes de biológicos tem despertado o interesse nos biossimilares.
O objectivo deste trabalho foi perceber se existe fundamento para as questões levantadas sobre os biossimilares do interferão (eficácia e segurança), rever o estado actual de aprovação e regulamentação, identificar os biossimilares do interferão existentes no círculo internacional e perceber se os mesmos têm as características necessárias para aprovação na Europa.
Métodos
Nesta revisão sistemática da literatura, a pesquisa foi efectuada através da análise de artigos científicos obtidos através de bases de dados online e sites, entre o período de Maio de 2013 a Janeiro de 2014.
Discussão
O único pedido de aprovação de um biossimilar do interferão data de 2006, o qual foi recusado. Os biossimilares encontrados foram de mercados emergentes. Os estudos centraram-se apenas na avaliação da eficácia e da segurança do fármaco. Não fizeram nenhuma referência a aspectos de qualidade ou ensaios não-clínicos.
Conclusão
É a União Europeia que apresenta as guidelines mais exigentes nesta área. Os biossimilares encontrados em países emergentes não apresentaram dados suficientes para uma possível submissão à aprovação na EMA. Todos os medicamentos biotecnológicos são imunogénicos e variáveis dentro dos limites controlados. As orientações regulamentares têm o mesmo grau de exigência para todos os biológicos.
The expiration of biological patents has aroused the interest in biosimilars. The aim of this study was to understand whether there is ground for the issues raised on biosimilar interferon (efficacy and safety), review the current state of regulatory approval, identify the existing biosimilar interferon in the international circle and see if they have the characteristics needed for approval in Europe. Methods In this systematic literature review, the research was carried out through the analysis of scientific papers obtained through online databases and web sites, between the period, May 2013 to January 2014. Discussion The only application for approval of a biosimilar interferon of 2006, which was refused. Biosimilars were found in emerging markets. The studies focused only on evaluating the effectiveness and safety of the drug. They made no reference to aspects of quality or non- clinical trials. Conclusion It is the EU that has the highest guidelines in this area. Biosimilars found in emerging countries did not show sufficient for possible submission to the EMA approval data. All biotech drugs are immunogenic and variables within controlled limits. Regulatory guidelines have the same level of demand for all organic.
The expiration of biological patents has aroused the interest in biosimilars. The aim of this study was to understand whether there is ground for the issues raised on biosimilar interferon (efficacy and safety), review the current state of regulatory approval, identify the existing biosimilar interferon in the international circle and see if they have the characteristics needed for approval in Europe. Methods In this systematic literature review, the research was carried out through the analysis of scientific papers obtained through online databases and web sites, between the period, May 2013 to January 2014. Discussion The only application for approval of a biosimilar interferon of 2006, which was refused. Biosimilars were found in emerging markets. The studies focused only on evaluating the effectiveness and safety of the drug. They made no reference to aspects of quality or non- clinical trials. Conclusion It is the EU that has the highest guidelines in this area. Biosimilars found in emerging countries did not show sufficient for possible submission to the EMA approval data. All biotech drugs are immunogenic and variables within controlled limits. Regulatory guidelines have the same level of demand for all organic.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2014
Palavras-chave
Biossimilares Interferão EMA Proteínas Esclerose múltipla Mestrado Integrado - 2014