Cargando…

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the c...

Descripción completa

Detalles Bibliográficos
Autores principales: Halimi, Vesa, Daci, Armond, Ancevska Netkovska, Katerina, Suturkova, Ljubica, Babar, Zaheer-Ud-Din, Grozdanova, Aleksandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460311/
https://www.ncbi.nlm.nih.gov/pubmed/32796549
http://dx.doi.org/10.3390/ijerph17165800
_version_ 1783576572082520064
author Halimi, Vesa
Daci, Armond
Ancevska Netkovska, Katerina
Suturkova, Ljubica
Babar, Zaheer-Ud-Din
Grozdanova, Aleksandra
author_facet Halimi, Vesa
Daci, Armond
Ancevska Netkovska, Katerina
Suturkova, Ljubica
Babar, Zaheer-Ud-Din
Grozdanova, Aleksandra
author_sort Halimi, Vesa
collection PubMed
description Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP’s key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars.
format Online
Article
Text
id pubmed-7460311
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-74603112020-09-02 Clinical and Regulatory Concerns of Biosimilars: A Review of Literature Halimi, Vesa Daci, Armond Ancevska Netkovska, Katerina Suturkova, Ljubica Babar, Zaheer-Ud-Din Grozdanova, Aleksandra Int J Environ Res Public Health Review Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP’s key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars. MDPI 2020-08-11 2020-08 /pmc/articles/PMC7460311/ /pubmed/32796549 http://dx.doi.org/10.3390/ijerph17165800 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Halimi, Vesa
Daci, Armond
Ancevska Netkovska, Katerina
Suturkova, Ljubica
Babar, Zaheer-Ud-Din
Grozdanova, Aleksandra
Clinical and Regulatory Concerns of Biosimilars: A Review of Literature
title Clinical and Regulatory Concerns of Biosimilars: A Review of Literature
title_full Clinical and Regulatory Concerns of Biosimilars: A Review of Literature
title_fullStr Clinical and Regulatory Concerns of Biosimilars: A Review of Literature
title_full_unstemmed Clinical and Regulatory Concerns of Biosimilars: A Review of Literature
title_short Clinical and Regulatory Concerns of Biosimilars: A Review of Literature
title_sort clinical and regulatory concerns of biosimilars: a review of literature
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460311/
https://www.ncbi.nlm.nih.gov/pubmed/32796549
http://dx.doi.org/10.3390/ijerph17165800
work_keys_str_mv AT halimivesa clinicalandregulatoryconcernsofbiosimilarsareviewofliterature
AT daciarmond clinicalandregulatoryconcernsofbiosimilarsareviewofliterature
AT ancevskanetkovskakaterina clinicalandregulatoryconcernsofbiosimilarsareviewofliterature
AT suturkovaljubica clinicalandregulatoryconcernsofbiosimilarsareviewofliterature
AT babarzaheeruddin clinicalandregulatoryconcernsofbiosimilarsareviewofliterature
AT grozdanovaaleksandra clinicalandregulatoryconcernsofbiosimilarsareviewofliterature