Drug interchangeability: an integrative review on pharmaceutical equivalence and clinical evidence
DOI:
https://doi.org/10.69849/zp183686Keywords:
Generic drugs, Bioequivalence, Pharmaceutical equivalence, Drug interchangeability, Health regulationAbstract
The interchangeability between generic and reference drugs is a pillar of public health policies in Brazil. In order to systematize the available scientific evidence on the subject, an integrative literature review was conducted including publications from 2020 to 2025, in Portuguese and English, obtained from PubMed/MEDLINE, SciELO, Scopus, Web of Science, and Google Scholar databases. Of the 146 studies initially identified, 14 met the inclusion criteria and constitute the final analysis. The results showed that, in most studies, generic drugs presented pharmacokinetic parameters, especially Cmax and AUC, within the range of 80% to 125%, confirming bioequivalence with their respective reference products. In clinical outcomes such as cure rates, mortality, and adverse events, no statistically significant differences were observed. However, the review highlighted the limitations of the average bioequivalence (ABE) methodology in specific subpopulations and for narrow therapeutic index drugs. It is concluded that interchangeability between generics and reference drugs is scientifically grounded and safe, with consistent evidence across several therapeutic classes.
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Copyright (c) 2026 Lorraine Beatriz Silva, Pedro Henrique de Paula Brito, Gérsika Bitencourt Santos Barros (Autor)
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