Bioequivalence: health, commercial and political implications of this technical tool

Abstract

Bioequivalence (BE) is a clinical-pharmacological research method that has acquired great relevancein most of the countries due to its health, commercial, and political importance. Some regulatoryagencies require routine BE for all products registered in their national territory, while others opt forpolicies that require this study only for certain products. The truth is that even today there are currentdebates about its definition, its clinical relevance and the level of requirements that each country mustask to those companies that aim to register a new product.The objective of this paper is to provide different perspectives on the concept of bioequivalent drugs,establish what are the advantages or disadvantages of adopting different policies on BE, identify theinterests associated with this concept and clarify its real importance for public health.