Resumo

NOGUERA PENA, Alfonso  e  CASTILLO RODRIGUEZ, Carlos del. Biosimilar drugs as essential drugs: ethical and legal reflections. Med. ética [online]. 2023, vol.34, n.2, pp.481-520.  Epub 30-Jun-2023. ISSN 2594-2166.  https://doi.org/10.36105/mye.2023v34n2.05.

This article reflects on the regulatory reforms that have taken place in recent decades with respect to the rational use of drugs, and the measures taken to reduce pharmaceutical expenditure. In this context, the high cost of biological therapies and the difficulties of access to them -especially in developing countries- should be highlighted.

Biosimilar drugs have analogous health guarantees -similar or equivalent- to reference drugs but are not subject to patent protection and facilitate accessibility for patients, as well as the equitable distribution of therapeutic resources. In addition, some of them are included in the list of essential drugs of the World Health Organization (WHO).

The role of biosimilar drugs as essential drugs and the possibility of improving equitable access to these health resources through pharmaceutical provision are also examined.

Palavras-chave : public health; accessibility; universal access; generic drugs; intellectual property.