Abstract

NOGUERA PENA, ALFONSO  and  DEL CASTILLO RODRIGUEZ, CARLOS. Balance between Innovation and Health Public Expenditure. The Particular Case of Biosimilars. Rev. Derecho Estado [online]. 2021, n.48, pp.273-296.  Epub May 05, 2021. ISSN 0122-9893.  https://doi.org/10.18601/01229893.n48.10.

Biosimilar medicines have been commercialized in the European regulatory territory for thirteen years. Its commercialization has not been exempted from multiple criticisms, especially the confusions about its erroneous equivalence with generic medicines and the doubts generated regarding its possibility of interchangeability and substitution. In this work we expose that, the development of biosimilar medicines introduces competition in the pharmaceutical market, and, innovation in the health sector is encouraged. In addition, given that biosimilar medicines are distributed at lower prices than the original biological medicines, they also facilitate the accessibility of treatments to patients, and contribute to the sustainability of public health systems.

Keywords : Pharmaceutical Law; regulatory framework; biological medicines; patents; National Health System.

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