Reumatología Clínica (English Edition) Reumatología Clínica (English Edition)
Reumatol Clin 2017;13:287-93 - Vol. 13 Num.5 DOI: 10.1016/j.reumae.2016.05.014
Review Article
Biosimilars: A New Scenario in Biologic Therapies
Fármacos biosimilares: un nuevo escenario en las terapias biológicas
José M. Serra López-Matencioa, Alberto Morell Baladróna, Santos Castañedab,, ,
a Servicio de Farmacia Hospitalaria, Hospital de La Princesa, IIS-IP, Universidad Autónoma, Madrid, Spain
b Servicio de Reumatología, Hospital de La Princesa, IIS-IP, Universidad Autónoma, Madrid, Spain
Received 23 November 2015, Accepted 22 May 2016
Abstract

There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events.

Resumen

No cabe duda de que los productos biológicos aportan un valor añadido a los sistemas de salud, aunque también plantean grandes interrogantes debido a su especial naturaleza, lo que obliga a ser muy rigurosos y exigentes en su control de calidad y seguimiento. Este hecho se ha visto reforzado por la entrada en escena de los fármacos biosimilares, cuyo menor coste está permitiéndoles alcanzar un mayor protagonismo en el mercado mundial. El propósito de este artículo es revisar en profundidad los principales interrogantes que se plantean en su producción, distribución y control, así como los aspectos más importantes relacionados con su seguridad en la práctica clínica. En este trabajo revisamos lo que representa la farmacovigilancia de estos productos, prestando especial atención a su trazabilidad, como herramienta fundamental para la detección precoz de acontecimientos adversos.

Keywords
Biologics, Biosimilars, Pharmacovigilance, Traceability, Adverse reactions, Legislation
Palabras clave
Biológicos, Biosimilares, Farmacovigilancia, Trazabilidad, Acontecimientos adversos, Legislación

Article

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Reumatol Clin 2017;13:287-93 - Vol. 13 Num.5 DOI: 10.1016/j.reumae.2016.05.014
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