Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars
ABSTRACTObjectives 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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-12-01
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| Series: | Journal of Market Access & Health Policy |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/20016689.2022.2147286 |
| _version_ | 1797226034935889920 |
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| author | Sarfaraz K. Niazi Waleed Mohammed Al-Shaqha Zafar Mirza |
| author_facet | Sarfaraz K. Niazi Waleed Mohammed Al-Shaqha Zafar Mirza |
| author_sort | Sarfaraz K. Niazi |
| collection | DOAJ |
| description | ABSTRACTObjectives 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. |
| first_indexed | 2024-03-11T11:56:54Z |
| format | Article |
| id | doaj.art-847ac441fe1e4db89386da72604158ff |
| institution | Directory Open Access Journal |
| issn | 2001-6689 |
| language | English |
| last_indexed | 2024-04-24T14:18:30Z |
| publishDate | 2023-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Market Access & Health Policy |
| spelling | doaj.art-847ac441fe1e4db89386da72604158ff2024-04-03T08:11:24ZengMDPI AGJournal of Market Access & Health Policy2001-66892023-12-0111110.1080/20016689.2022.2147286Proposal of International Council for Harmonization (ICH) Guideline for the Approval of BiosimilarsSarfaraz K. Niazi0Waleed Mohammed Al-Shaqha1Zafar Mirza2College of Pharmacy, University of Illinois, Chicago, IL, USAPharmacology Department, College of Medicine, Imam Muhammad Ibn Saud Islamic University, Riyadh, Kingdom of Saudi ArabiaSchool of Universal Health Coverage, Shifa Tameer-i-Millat University, Islamabad, PakistanABSTRACTObjectives 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.https://www.tandfonline.com/doi/10.1080/20016689.2022.2147286BiosimilarsInternational Council for HarmonizationFood and Drug AdministrationEuropean Medicines Agencyglobal approvalregulatory guidance |
| spellingShingle | Sarfaraz K. Niazi Waleed Mohammed Al-Shaqha Zafar Mirza Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars Journal of Market Access & Health Policy Biosimilars International Council for Harmonization Food and Drug Administration European Medicines Agency global approval regulatory guidance |
| 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 | Biosimilars International Council for Harmonization Food and Drug Administration European Medicines Agency global approval regulatory guidance |
| url | https://www.tandfonline.com/doi/10.1080/20016689.2022.2147286 |
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