Response on bioequivalence for biotherapeutic drugs
PDF (Español)
XML (Español)

Keywords

Biological Products
Biosimilar Pharmaceuticals
Botulinum Toxins
Generic Drugs
Interchange of Drugs
Therapeutic Equivalency

Abstract

We have had the opportunity to read your letter related to our review article: "Biotherapeutic drugs: use of botulinum toxins in the era of biosimilars". We would like to express our agreement with your comments on the relevance of the subject in our environment, as well as with your reflections on the interchangeability of drugs and the need to clarify the concepts on the subject very well.

In particular, you refer to the confusion that can be generated by the phrase in our conclusion: "biological drugs are not interchangeable with each other, even if they demonstrate bioequivalence". With interest we read how many of our colleagues were confused with the last part of the sentence because it is contradictory, since as you classically mention "bioequivalence studies are carried out to demonstrate that the generic drug is equivalent and interchangeable with the original drug".

https://doi.org/10.22379/anc.v40i1.1219

PDF (Español)
XML (Español)

References

Martínez Trujillo DP. La bioequivalencia en los medicamentos bioterapeúticos. Acta Neurol Colomb. 2023;39(4):1212. https://doi.org/10.22379/anc.v39i4.1212

Martínez JD, Cavanzo P, Sobrino F, Ramírez S, Arango G, Zuluaga AF, Morales MV, Rendón L. Medicamentos bioterapéuticos: uso de toxinas botulínicas en la era de biosimilares. Acta Neurol Colomb. 2023:39(2):e867. https://doi.org/10.22379/anc.v39i2.867

Yang GH, Jung HH. A new botulinum toxin potentially bioequivalent to onabotulinumtoxinA: are there any differences at all? [published correction appears in Dermatol Surg. 2013;39(6):965]. Dermatol Surg. 2013;39(1 Pt 2):165-70. https://doi.org/10.1111/dsu.12073

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Downloads

Download data is not yet available.