Bioequivalence in biotherapeutic drugs
PDF (Español)
XML (Español)

Keywords

Therapeutic Equivalency
Drug Prescriptions
Biological Products
safety
Patients

Abstract

It is well known in the medical community that in some institutions there are difficulties with respect for the prescription of chemically synthesized drugs and biologics, based exclusively on commercial negotiations, and our colleagues are exposed to having to use and exchange drugs in a "mandatory" manner, with the respective consequences of safety and efficacy for patients, as well as the consequences on medical liability.

Medical literature and respect for the ethical principles of our medical practice are the only tools we have in this situation. Hence the importance, but also the great responsibility, of our efforts to produce scientific literature. Not only do we learn and update ourselves with it, we also use it to defend the rights of the people who are our patients.

After reading the article, I cannot understand, if we still do not have head-to-head comparative studies between the different toxins, how this, which is a literature review article, can talk about "biologic drugs are not interchangeable with each other, even if they demonstrate bioequivalence".

https://doi.org/10.22379/anc.v39i4.1212

PDF (Español)
XML (Español)

References

Martínez JD, Cavanzo P, Sobrino F, Ramírez S, Arango G, Zuluaga AF, Morales MV, Rendón L. Medica-mentos 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

Ranjan Gupta. Pharmacoviligence of biosimilars - Why is it different from generics and innovator biologics? J Postgrad. 2020;66(2):116. https://doi.org/10.4103/jpgm.JPGM_651_19

Oza B, Radhakrishna S, Pipalava P, Jose V. Pharmacovigilance of biosimilars - Why is it different from generics and innovator biologics? J Postgrad Med. 2019;65:227–32.

Pasina L, Casadej G, Nobili A. Biological agents and biosimilars: Essential information for the internist. Eur J Intern Med. 2016:33:28-35. https://doi.org/10.1016/j.ejim.2016.06.005

Weise M, Wolff-Holz E. Opportunities and challenges of extrapolation for biosimilars. Z Gastroenterol. 2016;54:1211-6. https://doi.org/10.1055/s-0042-116950

Weise M. From bioequivalence to biosimilars: How much do regulators dare? Z Evid Fortbild Qual Gesundhwes. 2019:140:58-62. https://doi.org/10.1016/j.zefq.2018.12.001

Wolff- Holz E, Tiitso K, Vleminckx C, Weise M. Evolution of the EU biosimilar framework: past and future. BioDrugs. 2019;33(6):621-34. https://doi.org/10.1007/s40259-019-00377-y

US Food and Drug Administration. Medicamentos genéricos: preguntas y respuestas; [citado 2023 Dic 2]. https://www.fda.gov/drugs/generic-drugs/medicamentos-genericos-preguntas-y-respuestas.

European Medicines Agency. Biosimilars in the EU. Information guide for healthcare professionals; [citado 2023 Dic 2]. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professiols

Invima. Bioequivalencia; [citado 2023 Dic 2]. https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/bioequivalencia

Baethge C, Goldbeck- Wood A, Mertens S. SANRA – a scale for the quality assessment of narrative review articles. Res Integr Peer Rev. 2019:4:5. https://doi.org/10.1186/s41073-019-0064-8

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.