Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of Candida albicans and Candida glabrata.

Alina Karoline Nussbaumer-Pröll,Jana Marx,René Welte,Sabine Eberl,Markus Zeitlinger,Tiziana Gasperetti,Romuald Bellmann

doi:10.3390/jof8020195

Abstract

Background: Concerns have been expressed about the interchangeability of innovator and generic antifungals in their activity and chemical stability. Materials/methods: The activity of two different antimycotics was tested, each with one originator and two generics. For voriconazole, the originator VFEND® (Pfizer) and the generics (Ratiopharm and Stada) were used for susceptibility testing (21 clinical isolates of Candida albicans (C. albicans); ATCC-90028 C. albicans) in RPMI growth media in compliance with the EUCAST criteria. Likewise, for anidulafungin, the originator ECALTA® (Pfizer) and the generics (Stada and Pharmore) were used for testing (20 clinical isolates of Candida glabrata (C. glabrata); ATCC-22019 Candida parapsilosis (C. parapsilosis)). Time Kill Curves (TKC) with concentrations above and below the respective MIC were performed for one strain for each antifungal. Stability testing of the antimycotics stored at 4 °C and at room temperature over 24 h was done, and samples were subsequently analyzed with HPLC. Results: MIC results showed no significant difference in activity of generic and innovator antimycotic in all settings, which was also confirmed by TKC. Stability testing revealed no differences between originator and generic drugs. Conclusions: The present study demonstrates the interchangeability of generic and originator antimycotic in-vitro, potentially leading to broader public acceptance for generic antimycotics.

Highlights

Published: 17 February 2022Generic drugs become more and more available on the market, which helps reduce health care associated costs [1]
Public concerns have been expressed about the interchangeability of innovator and generic
Most of these studies compare the pharmacokinetic properties of the tested drugs to show the interchangeability of generic and originator

Summary

Introduction

Generic drugs become more and more available on the market, which helps reduce health care associated costs [1]. No or only a few further measures are taken before a generic drug is released on the market [2]. Studies have been conducted in different fields, e.g., antibacterial and antiviral agents, to pursue public doubts. Most of these studies compare the pharmacokinetic properties of the tested drugs to show the interchangeability of generic and originator. A recent study compared the pharmacokinetics of two hepatitis C direct-acting antivirals, sofosbuvir, and daclatasvir, from 5 different generic companies, which could confirm that the generic drugs were bioequivalent to the originator [3]

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Results

Conclusion