Régimen jurídico-administrativo y garantías sanitarias de los medicamentos biosimilares

Abstract

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...