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Comment on “Interchangeability between Generic and Reference Products: Limits of Average Bioequivalence Methodology”

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European Journal of Drug Metabolism and Pharmacokinetics Aims and scope Submit manuscript

A Letter to the Editor (invited) to this article was published on 21 January 2023

The Original Article was published on 19 August 2022

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Data availability

Data sharing not applicable to this article as no datasets were generated or analysed during the current study. The Levothyrox shelf life data are owned by a third party with no access to the corresponding author.

References

  1. Chow S-C, Liu J-P. Design and analysis of bioavailability and bioequivalence studies. 3rd ed. Chapman & Hall/CRC: Taylor & Francis Group; 2009.

  2. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, Yang Y, Yu LX, Woodcock J. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583–97.

    Article  CAS  PubMed  Google Scholar 

  3. Gwaza L, Gordon J, Welink J, Potthast H, Hansson H, Stahl M, Garcia-Arieta A. Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO. Eur J Clin Pharmacol. 2012;68(12):1611–8.

    Article  PubMed  Google Scholar 

  4. Herranz M, Morales-Alcelay S, Corredera-Hernandez MT, de la Torre-Alvarado JM, Blazquez-Perez A, Suarez-Gea ML, Alvarez C, García-Arieta A. Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison. Eur J Clin Pharmacol. 2013;69(5):1157–62.

    Article  CAS  PubMed  Google Scholar 

  5. Pejcic Z, Vucicevic K, Garcia-Alfredo A, Miljkovic B. Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia. Br J Clin Pharmacol. 2019;85:2059–65.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. Gottwald-Hostalek U, Uhl W, Wolna P, Kahaly GJ. New levothyroxine formulation meeting 95–105% specification over the whole shelf-life: results from two pharmacokinetic trials. Curr Med Res Opin. 2017;33(2):169–74.

    Article  CAS  PubMed  Google Scholar 

  7. Concordet D, Gandia P, Montastruc JL, Bousquet-Melou A, Lees P, Ferran A, Toutain PL. Levothyrox® new and old formulations: are they switchable for millions of patients? Clin Pharmacokinet. 2019;58(7):827–33.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Concordet D, Gandia P, Montastruc JL, Bousquet-Melou A, Lees P, Ferran AA, Toutain PL. Why were more than 200 subjects required to demonstrate the bioequivalence of a new formulation of levothyroxine with an old one? Clin Pharmacokinet. 2020;59(1):1–5.

    Article  PubMed  Google Scholar 

  9. Lechat P, Ropers J, Barre J, Mouly S. Comment on: “Levothyrox® new and old formulations: are they switchable for millions of patients?” Clin Pharmacokinet. 2019;58(10):1351–2.

    Article  PubMed  Google Scholar 

  10. Coste J, Bertagna X, Zureik M. Comment on: “Levothyrox® new and old formulations: are they switchable for millions of patients?". Clin Pharmacokinet. 2019;58(7):965–6.

    Article  PubMed  Google Scholar 

  11. Munafo A, Krebs-Brown A, Gaikwad S, Urgatz B, Castello-Bridoux C. Comment on: “Levothyrox® new and old formulations: are they switchable for millions of patients?” Clin Pharmacokinet. 2019;58(7):969–71.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Krebs-Brown A, Munafo A, Gaikwad S, Urgatz B, Castello-Bridoux C. Comment on: “Why were more than 200 subjects required to demonstrate the bioequivalence of a new formulation of levothyroxine with an old one?” Clin Pharmacokinet. 2020;59(2):265–7.

    Article  PubMed  Google Scholar 

  13. Nicolas P. Comment on: “Levothyrox® new and old formulations: are they switchable for millions of patients?” Clin Pharmacokinet. 2019;58(7):959–60.

    Article  PubMed  Google Scholar 

  14. Nicolas P. Comment on: “Why were more than 200 subjects required to demonstrate the bioequivalence of a new formulation of levothyroxine with an old one?” Clin Pharmacokinet. 2020;59(2):273–5.

    Article  PubMed  Google Scholar 

  15. Yu Y, Maliepaard M. Comment on: “Levothyrox® new and old formulations: are they switchable for millions of patients?” Clin Pharmacokinet. 2020;59(2):281–2.

    Article  PubMed  Google Scholar 

  16. EMA guideline : Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg and 200 mcg (and additional strengths within the range) product-specific bioequivalence guidance. https://www.ema.europa.eu/en/documents/scientific-guideline/levothyroxine-tablets-125-mcg-25-mcg-50-mcg-75-mcg-100-mcg-200-mcg-additional-strengths-within-range_en.pdf. Accessed 16 Nov 2022.

  17. Dray-Spira R., Colas S., Bertrand M., Zureik M. Conséquences du passage à la nouvelle formule du Lévothyrox en France. Etude de pharmaco-épidémiologie à partir du système national des données de santé (SNDS). Rapport final Juin 2019. Available at: https://www.epi-phare.fr/rapports-detudes-et-publications/consequences-du-passage-a-la-nouvelle-formule-du-levothyrox-en-france/. Accessed 16 Nov 2022.

  18. Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Association between generic-to-generic levothyroxine switching and thyrotropin levels among US adults. JAMA Intern Med. 2022;182(4):418–25.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Lechat P. Interchangeability between generic and reference products: limits of average bioequivalence methodology. Eur J Drug Metab Pharmacokinet. 2022;47(6):777–87.

    Article  CAS  PubMed  Google Scholar 

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Author information

Authors and Affiliations

  1. School of Medicine, Paris 13 University, Bobigny, France

    Patrick Nicolas

  2. CHU Avicenne – Service de Biochimie – Pharmacologie, Bobigny, France

    Patrick Nicolas

  3. Assistance Publique des Hôpitaux de Paris, Paris, France

    Patrick Nicolas

  4. Emeritus Professor of Endocrinology, Paris Descartes School of Medicine, Paris 5 University, Paris, France

    Xavier Bertagna

Authors
  1. Patrick Nicolas
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  2. Xavier Bertagna
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Contributions

Both authors made equal contributions to the conception of the work and approved the version to be published.

Corresponding author

Correspondence to Patrick Nicolas.

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Conflict of Interest

Patrick Nicolas and Xavier Bertagna declare that they have no conflicts of interest.

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Nicolas, P., Bertagna, X. Comment on “Interchangeability between Generic and Reference Products: Limits of Average Bioequivalence Methodology”. Eur J Drug Metab Pharmacokinet 48, 213–215 (2023). https://doi.org/10.1007/s13318-022-00814-4

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  • DOI: https://doi.org/10.1007/s13318-022-00814-4

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