Cargando…
Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars
OBJECTIVES: Since the initial release of biosimilars 18 years ago, regulations for their licensing have changed considerably; however, there is no global consensus on these regulations. Establishing harmonized regulatory guidelines for the approval of biosimilars with support from the ICH, an indepe...
Autores principales: | , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Routledge
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9677983/ https://www.ncbi.nlm.nih.gov/pubmed/36419638 http://dx.doi.org/10.1080/20016689.2022.2147286 |
_version_ | 1784833904921804800 |
---|---|
author | Niazi, Sarfaraz K. Al-Shaqha, Waleed Mohammed Mirza, Zafar |
author_facet | Niazi, Sarfaraz K. Al-Shaqha, Waleed Mohammed Mirza, Zafar |
author_sort | Niazi, Sarfaraz K. |
collection | PubMed |
description | OBJECTIVES: Since the initial release of biosimilars 18 years ago, regulations for their licensing have changed considerably; however, there is no global consensus on these regulations. Establishing harmonized regulatory guidelines for the approval of biosimilars with support from the ICH, an independent, non-profit association under Swiss law, will significantly enhance the affordability of biological drugs. METHODS: Regulatory guidelines from the Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and World Health Organization (WHO) were analyzed for historical changes and elements critical to the safety and efficacy of biosimilars. RESULTS: Analysis of all EMA and FDA filings show that none of the animal testing and clinical efficacy testing failed because animals do not have the required receptors to initiate pharmacologic responses, and efficacy studies cannot be statistically powered to conclude any results. New analytical technologies will enable good biosimilarity determination, avoiding both tests. CONCLUSION: Scientifically based ICH guidelines that remove redundant studies will reduce development costs, improve safety, and allow global drug distribution based on single compliance. These guidelines are particularly necessary for emerging countries lacking the expertise and resources to evaluate biosimilar filings. |
format | Online Article Text |
id | pubmed-9677983 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Routledge |
record_format | MEDLINE/PubMed |
spelling | pubmed-96779832022-11-22 Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars Niazi, Sarfaraz K. Al-Shaqha, Waleed Mohammed Mirza, Zafar J Mark Access Health Policy Research Article OBJECTIVES: Since the initial release of biosimilars 18 years ago, regulations for their licensing have changed considerably; however, there is no global consensus on these regulations. Establishing harmonized regulatory guidelines for the approval of biosimilars with support from the ICH, an independent, non-profit association under Swiss law, will significantly enhance the affordability of biological drugs. METHODS: Regulatory guidelines from the Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and World Health Organization (WHO) were analyzed for historical changes and elements critical to the safety and efficacy of biosimilars. RESULTS: Analysis of all EMA and FDA filings show that none of the animal testing and clinical efficacy testing failed because animals do not have the required receptors to initiate pharmacologic responses, and efficacy studies cannot be statistically powered to conclude any results. New analytical technologies will enable good biosimilarity determination, avoiding both tests. CONCLUSION: Scientifically based ICH guidelines that remove redundant studies will reduce development costs, improve safety, and allow global drug distribution based on single compliance. These guidelines are particularly necessary for emerging countries lacking the expertise and resources to evaluate biosimilar filings. Routledge 2022-11-17 /pmc/articles/PMC9677983/ /pubmed/36419638 http://dx.doi.org/10.1080/20016689.2022.2147286 Text en © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Niazi, Sarfaraz K. Al-Shaqha, Waleed Mohammed Mirza, Zafar Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars |
title | Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars |
title_full | Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars |
title_fullStr | Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars |
title_full_unstemmed | Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars |
title_short | Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars |
title_sort | proposal of international council for harmonization (ich) guideline for the approval of biosimilars |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9677983/ https://www.ncbi.nlm.nih.gov/pubmed/36419638 http://dx.doi.org/10.1080/20016689.2022.2147286 |
work_keys_str_mv | AT niazisarfarazk proposalofinternationalcouncilforharmonizationichguidelinefortheapprovalofbiosimilars AT alshaqhawaleedmohammed proposalofinternationalcouncilforharmonizationichguidelinefortheapprovalofbiosimilars AT mirzazafar proposalofinternationalcouncilforharmonizationichguidelinefortheapprovalofbiosimilars |