Second phase of generic drugs in Brazil: implementation of the vasoconstrictor assay for dermatological topical corticosteroids
Vigil Sanit Debate, Rio de Janeiro, 2025, v.13: e02275 | Published on: 26/06/2025
DOI:
https://doi.org/10.22239/2317-269X.02275Keywords:
Therapeutic Equivalency, Generic, Adrenal Cortex Hormones, VasoconstrictionAbstract
Introduction: In Brazil, the sale of generic medicines has been increasing, driven by the search for more affordable alternatives. However, this expansion necessitates the assurance of safety and efficacy, particularly in the case of topical medications containing corticosteroids. Until 2022, these products were exempt from bioequivalence testing, with only pharmaceutical equivalence being required. Objective: This study aimed to discuss the registration of topical medications containing corticosteroids in Brazil, highlighting recent regulatory changes and the impact of the mandatory implementation of the Vasoconstrictor Assay (VCA). Method: The methodology consisted of a systematic review of scientific literature and national and international regulatory guidelines, focusing on the registration criteria for topical corticosteroid medications. The study provided a detailed examination of the VCA, a pharmacodynamic test that evaluates the degree of skin blanching following drug application, divided into a pilot study (defining Emax and ED50) and a main study (comparison with the reference product). Results: It was demonstrated that the VCA is widely adopted in international regulatory contexts, such as by the U.S. Food and Drug Administration (FDA) since 1995. In Brazil, its introduction presents a technical challenge, as most bioequivalence centers require appropriate expertise and infrastructure. Nevertheless, studies indicate that the method has the potential to effectively demonstrate bioequivalence. Conclusions: The requirement of the VCA represents a regulatory milestone in Brazil, fostering greater technical rigor in the registration of topical corticosteroid medications. Its adoption is essential to ensure the quality, safety, and efficacy of these products for the population.
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Author Biographies
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Leila Bastos Leal, Núcleo de Desenvolvimento Farmacêutico e Cosmético (NUDFAC), Universidade Federal de Pernambuco (UFPE), Recife, PE, Brasil
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Irla Carla de França Barbosa, Núcleo de Desenvolvimento Farmacêutico e Cosmético (NUDFAC), Universidade Federal de Pernambuco (UFPE), Recife, PE, Brasil
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Cristiano Ferraz, Núcleo de Desenvolvimento Farmacêutico e Cosmético (NUDFAC), Universidade Federal de Pernambuco (UFPE), Recife, PE, Brasil
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Davi Pereira de Santana, Núcleo de Desenvolvimento Farmacêutico e Cosmético (NUDFAC), Universidade Federal de Pernambuco (UFPE), Recife, PE, Brasil
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