Publication: Régimen jurídico-administrativo y garantías sanitarias de los medicamentos biosimilares
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2021-11-30
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Universidad Complutense de Madrid
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Abstract
Los denominados «medicamentos biosimilares» básicamente son productos de naturaleza biológica (es decir, producidos mediante organismos vivos), que se desarrollan una vez que ha expirado la patente del medicamento biológico original o de referencia. Sin embargo, los medicamentos biosimilares no son medicamentos genéricos, debido fundamentalmente por la variabilidad inherente de los seres vivos y de los procesos implicados en las fases de su producción industrial. Por tanto, existen diferencias fisicoquímicas entre el medicamento de referencia y sus medicamentos biosimilares, las cuales pueden detectarse a través de técnicas analíticas sofisticadas. En esta tesis doctoral se examina el régimen jurídico-administrativo de los medicamentos biosimilares en el ordenamiento jurídico español. Desde la óptica del Derecho Administrativo, se analizan los diversos retos jurídicos a los que se enfrentan estos medicamentos durante todo el ciclo de vida. También se analizan los aspectos más controvertidos de la utilización de estos medicamentos con vistas a determinar su procedencia o improcedencia, realizándose cuando procede, la propuesta de reforma de la normativa actual...
Biosimilars are basically medicines of a biological nature (that is, produced by living organisms), which are developed after the patent on the original or reference biological medicine has expired. However, biosimilars are not generic drugs, mainly due to the inherent variability of biological systems and the processes involved in the phases of their industrial production. Therefore, there are physicochemical differences between the reference medicine and its biosimilar medicines, which can be detected through sophisticated analytical techniques.This Ph.D. Thesis examines the legal-administrative regime of biosimilar drugs in the Spanish legal system. From the point of view of Administrative Law, the various legal challenges faced by these drugs throughout their lifecycle are analysed. The most controversial aspects of the use of biosimilars have been also analysed in order to determine their provenance or inadmissibility, carrying out the proposed reform of the current regulations when appropriate...
Biosimilars are basically medicines of a biological nature (that is, produced by living organisms), which are developed after the patent on the original or reference biological medicine has expired. However, biosimilars are not generic drugs, mainly due to the inherent variability of biological systems and the processes involved in the phases of their industrial production. Therefore, there are physicochemical differences between the reference medicine and its biosimilar medicines, which can be detected through sophisticated analytical techniques.This Ph.D. Thesis examines the legal-administrative regime of biosimilar drugs in the Spanish legal system. From the point of view of Administrative Law, the various legal challenges faced by these drugs throughout their lifecycle are analysed. The most controversial aspects of the use of biosimilars have been also analysed in order to determine their provenance or inadmissibility, carrying out the proposed reform of the current regulations when appropriate...
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Tesis inédita de la Universidad Complutense de Madrid, Facultad de Farmacia, Departamento de Farmacia Galénica y Tecnología Alimentaria, leída el 21-07-2021