Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of <i>Candida albicans</i> and <i>Candida glabrata</i>

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 V...

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Main Authors: Alina Karoline Nussbaumer-Pröll, Sabine Eberl, René Welte, Tiziana Gasperetti, Jana Marx, Romuald Bellmann, Markus Zeitlinger
Format: Article
Language:English
Published: MDPI AG 2022-02-01
Series:Journal of Fungi
Subjects:
Online Access:https://www.mdpi.com/2309-608X/8/2/195
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author Alina Karoline Nussbaumer-Pröll
Sabine Eberl
René Welte
Tiziana Gasperetti
Jana Marx
Romuald Bellmann
Markus Zeitlinger
author_facet Alina Karoline Nussbaumer-Pröll
Sabine Eberl
René Welte
Tiziana Gasperetti
Jana Marx
Romuald Bellmann
Markus Zeitlinger
author_sort Alina Karoline Nussbaumer-Pröll
collection DOAJ
description 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<sup>®</sup> (Pfizer) and the generics (Ratiopharm and Stada) were used for susceptibility testing (21 clinical isolates of <i>Candida albicans</i> (<i>C. albicans</i>); ATCC-90028 <i>C. albicans</i>) in RPMI growth media in compliance with the EUCAST criteria. Likewise, for anidulafungin, the originator ECALTA<sup>®</sup> (Pfizer) and the generics (Stada and Pharmore) were used for testing (20 clinical isolates of <i>Candida glabrata</i> (<i>C. glabrata</i>); ATCC-22019 <i>Candida parapsilosis</i> (<i>C. parapsilosis</i>)). 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.
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spelling doaj.art-360d373da4b74a669face8891b29e7892023-11-23T20:38:18ZengMDPI AGJournal of Fungi2309-608X2022-02-018219510.3390/jof8020195Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of <i>Candida albicans</i> and <i>Candida glabrata</i>Alina Karoline Nussbaumer-Pröll0Sabine Eberl1René Welte2Tiziana Gasperetti3Jana Marx4Romuald Bellmann5Markus Zeitlinger6Department of Clinical Pharmacology, Medical University of Vienna, 1090 Vienna, AustriaDepartment of Clinical Pharmacology, Medical University of Vienna, 1090 Vienna, AustriaDepartment of Clinical Pharmacokinetics, Innsbruck Medical University, 6020 Innsbruck, AustriaDepartment of Clinical Pharmacokinetics, Innsbruck Medical University, 6020 Innsbruck, AustriaDepartment of Clinical Pharmacokinetics, Innsbruck Medical University, 6020 Innsbruck, AustriaDepartment of Clinical Pharmacokinetics, Innsbruck Medical University, 6020 Innsbruck, AustriaDepartment of Clinical Pharmacology, Medical University of Vienna, 1090 Vienna, AustriaBackground: 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<sup>®</sup> (Pfizer) and the generics (Ratiopharm and Stada) were used for susceptibility testing (21 clinical isolates of <i>Candida albicans</i> (<i>C. albicans</i>); ATCC-90028 <i>C. albicans</i>) in RPMI growth media in compliance with the EUCAST criteria. Likewise, for anidulafungin, the originator ECALTA<sup>®</sup> (Pfizer) and the generics (Stada and Pharmore) were used for testing (20 clinical isolates of <i>Candida glabrata</i> (<i>C. glabrata</i>); ATCC-22019 <i>Candida parapsilosis</i> (<i>C. parapsilosis</i>)). 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.https://www.mdpi.com/2309-608X/8/2/195antifungalsgenericinnovatorMICTKC<i>C. albicans</i>
spellingShingle Alina Karoline Nussbaumer-Pröll
Sabine Eberl
René Welte
Tiziana Gasperetti
Jana Marx
Romuald Bellmann
Markus Zeitlinger
Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of <i>Candida albicans</i> and <i>Candida glabrata</i>
Journal of Fungi
antifungals
generic
innovator
MIC
TKC
<i>C. albicans</i>
title Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of <i>Candida albicans</i> and <i>Candida glabrata</i>
title_full Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of <i>Candida albicans</i> and <i>Candida glabrata</i>
title_fullStr Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of <i>Candida albicans</i> and <i>Candida glabrata</i>
title_full_unstemmed Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of <i>Candida albicans</i> and <i>Candida glabrata</i>
title_short Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates of <i>Candida albicans</i> and <i>Candida glabrata</i>
title_sort comparison of antimycotic activity of originator and generics of voriconazole and anidulafungin against clinical isolates of i candida albicans i and i candida glabrata i
topic antifungals
generic
innovator
MIC
TKC
<i>C. albicans</i>
url https://www.mdpi.com/2309-608X/8/2/195
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