Skip to main content
SpringerLink
Log in

Response to Comment on “Interchangeability Between Generic and Reference Products: Limits of Average Bioequivalence Methodology”

  • Letter to the Editor (invited)
  • Published:
European Journal of Drug Metabolism and Pharmacokinetics Aims and scope Submit manuscript

The Original Article was published on 21 January 2023

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Nicolas P, Bertagna X. Comment on “Interchangeability between generic and reference products: limits of average bioequivalence methodology”. Eur J Drug Metab Pharmacokinet. 2023. https://doi.org/10.1007/s13318-022-00814-4.

  2. 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 

  3. Chen ML, Rabindra P, Hauck WW, Schuirmann DJ, Hyslop T, Williams R. An individual bioequivalence criterion: regulatory considerations. Stat Med. 2000;19:2821–42.

    Article  CAS  PubMed  Google Scholar 

  4. Yu Y, Teerenstra S, Neef C, Burger D, Maliepaard M. A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate designs. Br J Clin Pharmacol 2015;81:667-78.

    Article  Google Scholar 

  5. FDA Draft guidance on Levothyroxin. 2014. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levothyroxine_Sodium%20capsules_NDA%20021924_RC%20Oct%202018.pdf. Accessed 12 Dec 2022.

  6. FDA draft guidance on warfarin sodium. 2012. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Warfarin_Sodium_tab_09218_RC12-12.pdf. Accessed 12 Dec 2022.

  7. Van Lancker G, Van Bortel L, Delafontaine B, et al. Switchability of gabapentin formulations: a randomized trial to assess bioequivalence between neurontin and gabasandoz on the individual subject level. Clin Pharmacol Ther. 2019;106:195–203.

    Article  PubMed  Google Scholar 

  8. 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-etpublications/consequences-du-passage-a-la-nouvelle-formule-du-levothyrox-en-france/. Accessed 16 Nov 2022.

  9. ANSM pharmacovigilance report on Levothyrox: Actualité—Médicaments à base de lévothyroxine: l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance—ANSM (sante.fr). Accessed 12 Dec 2022.

  10. Concordet D, Gandia P, Montastruc JL, et al. Levothyrox® new and old formulations: are they switchable for millions of patients? Clin Pharmacokinet. 2019;58:827–33.

    Article  PubMed  PubMed Central  Google Scholar 

  11. 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. 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 (europa.eu). Accessed 12 Dec 2022.

  12. 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;33:169–74.

    Article  CAS  PubMed  Google Scholar 

  13. Fliers E, Demeneix B, Bhaseen A, Brix TH. European Thyroid Association (ETA) and Thyroid Federation International (TFI) joint position statement on the interchangeability of levothyroxine products in EU countries. Eur Thyroid J. 2018;7(5):238–42.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Emeritus Professor, Paris-City University, Paris, France

    Philippe Lechat

  2. Georges Pompidou European Hospital, Pharmacology Department and Medicine Evaluation Unit, Agence Générale des Equipements et des Produits de Santé (AGEPS), Assistance Publique des Hôpitaux de Paris, Paris, France

    Philippe Lechat

Authors
  1. Philippe Lechat
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Philippe Lechat.

Ethics declarations

Funding

No funding sources were used to prepare the response.

Conflict of interest

The author has no conflicts of interest to declare.

Ethic approval

Not applicable.

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and material

Not applicable.

Code availability

Not applicable.

Author contributions

PL wrote the response.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Lechat, P. Response to Comment on “Interchangeability Between Generic and Reference Products: Limits of Average Bioequivalence Methodology”. Eur J Drug Metab Pharmacokinet 48, 217–219 (2023). https://doi.org/10.1007/s13318-022-00813-5

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13318-022-00813-5

Search

Navigation