Revisión del uso de los medicamentos biosimilares vs. biológicos: implicaciones para la salud en Colombia.
| Contribuinte(s) |
González, Javier |
|---|---|
| Data(s) |
20/04/2016
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| Resumo |
Este documento tiene como objetivo describir las implicaciones para la salud con el uso de medicamentos biosimilares en comparación con los medicamentos biológicos en Colombia. Así mismo, describir el contexto normativo acerca del uso de medicamentos biosimilares, las recomendaciones y lineamientos sobre seguridad y efectividad del uso de medicamentos Biosimilares y Biológicos, partiendo de sus diferencias biomoleculares. Para esto, se desarrolló una revisión documental electrónica y manual de la literatura en bases de datos, revistas y libros limitada a términos MeSH. La selección de los artículos incluyo documentos completos publicados en revistas indexadas de los últimos 10 años, en español e inglés; la información recolectada se organizó para la construcción del presente documento. Concluyendo, se encontró que las patentes de muchos medicamentos biológicos han vencido o están próximas a caducar y varios biosimilares están desarrollándose y comercializándose incluso en países sin regulaciones estrictas. Los biosimilares nunca podrán ser iguales al original por su complejidad molecular, por ello debemos integrarlos a los sistemas de farmacovigilancia mejorando trazabilidad e identificando su origen mientras se establecen denominaciones comunes distinguibles. La evidencia actual sugiere que la regulación de medicamentos biosimilares debe ser evaluada y armonizada en todo el mundo. Centro de Estudios Empresariales para la perdurabilidad This paper aims to describe the health implications with the use of biosimilars compared with biological drugs in Colombia. Also, described the regulatory context about the use of biosimilars, recommendations and guidelines on safety and effectiveness of using biosimilar and biological medicines, based on their biomolecular differences. For this, an electronic document review and manual literature databases, magazines and books limited MeSH terms was developed. The selection of items included full papers published in indexed journals from last 10 years, in Spanish and English; the information collected was organized for the construction of this document. In conclusion, we found that many biological drugs patents have expired or are close to expiring and several biosimilars are being developed and marketed even in countries without strict regulations. Biosimilars can never be equal to the original by their molecular complexity, so we must integrate pharmacovigilance systems to improve traceability and identify their origin while distinguishable nonproprietary names are set. Current evidence suggests that regulation of biosimilar medicines should be evaluated and harmonized worldwide. |
| Formato |
application/pdf |
| Identificador | |
| Idioma(s) |
spa |
| Publicador |
Facultad de administración |
| Direitos |
info:eu-repo/semantics/openAccess |
| Fonte |
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| Palavras-Chave | #Administración de servicios de salud #Salud pública #362.1068 #Administración hospitalaria #Biosimilares farmacéuticos #Vigilancia en salud pública #Biosimilars #Biologicals #Pharmacovigilance #traceability #immunogenicity |
| Tipo |
info:eu-repo/semantics/masterThesis info:eu-repo/semantics/acceptedVersion |
