Más sobre intercambiabilidad y sustitución de medicamentos biológicos

The selection, interchangeability and substitution of biological medicines have been hot topics
in Spanish pharmaceutical law for many years. In 2014, a Non-Legislative Proposal was presented to
Congress urging the Government to ‘Approve, as soon as possible, specific regulations on the substitution and interchangeability of biosimilar medicines’. Since then, legal arguments for and against substitution have been constructed. In this context, and after learning about the regulations approved in France in February 2025 regarding the substitution of biological medicines, the author proposes a review of the situation and the possibility of Spain adopting regulations similar to those in France.