Registration of generic dermatologic topical medications: Brazilian scenario and studies to demonstrate bioequivalence

Abstract

Comparing the number of approvals granted for topical drug products by the FDA and by Anvisa, as well as the number of tests required by these and other international agencies at the time of registration, it becomes clear that the increased flexibility of the Brazilian regulatory requirements has resulted in a larger number of topical medicines on the market, without a guarantee of bioequivalence between the different formulations considered generic. For this reason, the aim of this study is to discuss, from the point of view of Brazilian researchers, the methodologies that could possibly be used in Brazil for the reasons mentioned above, the most urgent being a revaluation of Brazilian legislation concerning bioequivalence of these products. Among the approaches considered are: in vitro release test, in vitro permeation, pharmacodynamic test (only for corticoids), and dermatopharcokinetic and dermal microdialysis. We conclude that, firstly, based on the simplicity of the methods, as well as the ease for their implementation, parameters for the in vitro approach must be defined. Later, a wider discussion involving Anvisa, the scientific community and the industrial sector should be sought, aiming to assess the technical and economic viability of the adaptation to the Brazilian scenario in relation to the use of the in vivo methods discussed here.