Registro sanitario de medicamentos biológicos y biotecnológicos en América Latina
Fecha
2021
Tipo
artículo original
Autores
Ramírez Telles, Mariana
Mora Román, Juan José
Fallas Cartín, Milena
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Resumen
Introducción: los medicamentos biológicos se definen como productos cuyos ingredientes activos son producidos por una fuente biológica, mientras que un producto biotecnológico se desarrolla a partir del aislamiento de un gen de interés y su clonación.Método: se realizó un estudio comparativo de las regulaciones vigentes a julio de 2020 relacionadas con medica-mentos biológicos y biotecnológicos de los países de Centroamérica y el Caribe que actualmente disponen de un marco regulatorio para su registro, con respecto a aquellas de Chile y Brasil.Resultados: existen diferencias relevantes en diversos aspectos. Dentro de la información general solicitada se en-contraron variaciones para las definiciones de autoridad reguladora de referencia, producto biotecnológico, pro-ducto de referencia y producto innovador. También se hallaron divergencias para la información no clínica y clínica solicitada, y los programas de farmacovigilancia. Para productos biosimilares se distinguieron particularidades ref-erentes a su definición y la de ejercicio de biosimilitud, así como para aspectos propios de su utilización como lo son la extrapolación de indicaciones y la sustitución automática o intercambiabilidad. Finalmente, para su etiquetado se requiere mayor estudio por parte de las autoridades sanitarias.Conclusiones: una vez realizada la revisión de la normativa respecto al registro sanitario de productos biológicos y biotecnológicos en nueve países de América Latina, se encontró que la información solicitada no se halla ho-mologada.
Introduction: biological products are defined as products whose active ingredients are produced by a biological source, while biotechnological medicine is developed from the isolation of a gene of interest and its cloning.Method: a comparative study was carried out of the regulations in force as of July 2020 related to biological and bio-technological drugs of the countries of Central America and the Caribbean that currently have a regulatory frame-work for their registration, with respect to those of Chile and Brazil.Results: there are relevant differences in various aspects. Within the general information requested, variations were found for the definitions of Stringent Regulatory Authority, biotechnological product, reference product, and innovative product. Also, divergences were found for the non-clinical and clinical information requested and the Pharmacovigilance programs. For biosimilar products, particularities were distinguished regarding their definition and the exercise of biosimilarity, as well as for aspects of their use, such as the extrapolation of indications and automatic substitution or interchangeability. Finally, their labeling requires further study by the health regulatory authorities.Conclusions: after reviewing the regulations for the marketing authorization of biological and biotechnological products in nine Latin American countries, it was found that the requested information is not homologated.
Introduction: biological products are defined as products whose active ingredients are produced by a biological source, while biotechnological medicine is developed from the isolation of a gene of interest and its cloning.Method: a comparative study was carried out of the regulations in force as of July 2020 related to biological and bio-technological drugs of the countries of Central America and the Caribbean that currently have a regulatory frame-work for their registration, with respect to those of Chile and Brazil.Results: there are relevant differences in various aspects. Within the general information requested, variations were found for the definitions of Stringent Regulatory Authority, biotechnological product, reference product, and innovative product. Also, divergences were found for the non-clinical and clinical information requested and the Pharmacovigilance programs. For biosimilar products, particularities were distinguished regarding their definition and the exercise of biosimilarity, as well as for aspects of their use, such as the extrapolation of indications and automatic substitution or interchangeability. Finally, their labeling requires further study by the health regulatory authorities.Conclusions: after reviewing the regulations for the marketing authorization of biological and biotechnological products in nine Latin American countries, it was found that the requested information is not homologated.
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Palabras clave
medicamentos biológicos, medicamentos biosimilares, registro de medicamentos, legislación farmacéutica, Biological products, Biosimilar pharmaceuticals, Products registration, Pharmacy legislation