Equivalence, Similarity, Comparability, and Inter-Changeability of Pharmaceuticals: The Difficult way to Their Practical Application in Italy

Equivalenza, comparabilità e sovrapponibilità terapeutica: mettiamo un po' di ordine

Abstract

Arising with the launch of generic drugs into the pharmaceutical market, the issue of the equivalence among drugs has grown in the course of time, expanding from chemical to biological and biotechnological substances. Far from being a merely academic topic, it implies a tangible clash of interests between providers (the industry) and buyers (public and private health care agencies) of an ever growing number of products. Regional, national and international regulations and laws are piling up, together with some confusion in such a complicated matter. This article aims to bring some clarity, starting from the terms used.