Bridging the gap: The future of biosimilars regulations
Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2362450 |
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| _version_ | 1849717219297067008 |
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| author | Anan S. Jarab Shrouq R Abu Heshmeh Ahmad Z. Al Meslamani |
| author_facet | Anan S. Jarab Shrouq R Abu Heshmeh Ahmad Z. Al Meslamani |
| author_sort | Anan S. Jarab |
| collection | DOAJ |
| description | Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and challenges that may be encountered. The current discrepancies in regulations across different countries, which pose significant challenges for the development and approval of biosimilar vaccines and immunotherapeutic products. These disparities often lead to delayed market access, increased development costs, and hindered innovation. The commentary stresses that such obstacles could be mitigated through harmonized regulations, resulting in faster approvals, reduced healthcare costs, and improved patient outcomes. Moreover, the commentary explores the specific complexities associated with biosimilar vaccines and immunotherapeutic, such as the intricate evaluation of biosimilarity due to their molecular composition and immunogenic properties. In conclusion, the editorial advocates for collaborative efforts to overcome the challenges in achieving global regulatory harmonization for biosimilars. This includes establishing uniform standards, fostering international cooperation among regulatory agencies, and promoting educational initiatives for healthcare providers and regulators. The ultimate goal is to ensure that patients worldwide have timely access to safe, effective, and affordable biosimilar treatments. |
| format | Article |
| id | doaj-art-7e5a8cbf4a9547d79b0b2409aaf1f6dc |
| institution | DOAJ |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-7e5a8cbf4a9547d79b0b2409aaf1f6dc2025-08-20T03:12:43ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2362450Bridging the gap: The future of biosimilars regulationsAnan S. Jarab0Shrouq R Abu Heshmeh1Ahmad Z. Al Meslamani2College of Pharmacy, Al Ain University, Abu Dhabi, UAEFaculty of pharmacy, Department of clinical pharmacy, Jordan University of Science and Technology, JordanCollege of Pharmacy, Al Ain University, Abu Dhabi, UAEBiosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and challenges that may be encountered. The current discrepancies in regulations across different countries, which pose significant challenges for the development and approval of biosimilar vaccines and immunotherapeutic products. These disparities often lead to delayed market access, increased development costs, and hindered innovation. The commentary stresses that such obstacles could be mitigated through harmonized regulations, resulting in faster approvals, reduced healthcare costs, and improved patient outcomes. Moreover, the commentary explores the specific complexities associated with biosimilar vaccines and immunotherapeutic, such as the intricate evaluation of biosimilarity due to their molecular composition and immunogenic properties. In conclusion, the editorial advocates for collaborative efforts to overcome the challenges in achieving global regulatory harmonization for biosimilars. This includes establishing uniform standards, fostering international cooperation among regulatory agencies, and promoting educational initiatives for healthcare providers and regulators. The ultimate goal is to ensure that patients worldwide have timely access to safe, effective, and affordable biosimilar treatments.https://www.tandfonline.com/doi/10.1080/21645515.2024.2362450BiosimilarsVaccinesImmunotherapeuticsBiopharmaceuticsGuidelinesRegulations |
| spellingShingle | Anan S. Jarab Shrouq R Abu Heshmeh Ahmad Z. Al Meslamani Bridging the gap: The future of biosimilars regulations Human Vaccines & Immunotherapeutics Biosimilars Vaccines Immunotherapeutics Biopharmaceutics Guidelines Regulations |
| title | Bridging the gap: The future of biosimilars regulations |
| title_full | Bridging the gap: The future of biosimilars regulations |
| title_fullStr | Bridging the gap: The future of biosimilars regulations |
| title_full_unstemmed | Bridging the gap: The future of biosimilars regulations |
| title_short | Bridging the gap: The future of biosimilars regulations |
| title_sort | bridging the gap the future of biosimilars regulations |
| topic | Biosimilars Vaccines Immunotherapeutics Biopharmaceutics Guidelines Regulations |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2362450 |
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