缩小差距:生物仿制药法规的未来。

IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-06-17 DOI:10.1080/21645515.2024.2362450
Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani
{"title":"缩小差距:生物仿制药法规的未来。","authors":"Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani","doi":"10.1080/21645515.2024.2362450","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2362450"},"PeriodicalIF":4.1000,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11188803/pdf/","citationCount":"0","resultStr":"{\"title\":\"Bridging the gap: The future of biosimilars regulations.\",\"authors\":\"Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani\",\"doi\":\"10.1080/21645515.2024.2362450\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":49067,\"journal\":{\"name\":\"Human Vaccines & Immunotherapeutics\",\"volume\":\"20 1\",\"pages\":\"2362450\"},\"PeriodicalIF\":4.1000,\"publicationDate\":\"2024-12-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11188803/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Human Vaccines & Immunotherapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/21645515.2024.2362450\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/6/17 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"BIOTECHNOLOGY & APPLIED MICROBIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Human Vaccines & Immunotherapeutics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/21645515.2024.2362450","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/17 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"BIOTECHNOLOGY & APPLIED MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

生物仿制疫苗和免疫疗法是医学研究的创新方法。本评论探讨了目前不同国家对生物仿制疫苗和免疫治疗产品监管的差异。它还介绍了全球统一监管的好处和可能遇到的挑战。目前不同国家的法规存在差异,这给生物仿制疫苗和免疫治疗产品的开发和审批带来了巨大挑战。这些差异往往导致市场准入延迟、开发成本增加和创新受阻。评注强调,这些障碍可以通过统一法规来缓解,从而加快审批速度、降低医疗成本并改善患者疗效。此外,评论还探讨了与生物仿制疫苗和免疫疗法相关的特殊复杂性,例如由于其分子组成和免疫原性,对生物仿制性的评估错综复杂。最后,社论倡导各方共同努力,克服在实现生物仿制药全球统一监管方面的挑战。这包括建立统一标准、促进监管机构之间的国际合作以及推动针对医疗服务提供者和监管机构的教育活动。最终目标是确保全球患者能够及时获得安全、有效和负担得起的生物仿制药治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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 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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Human Vaccines & Immunotherapeutics
Human Vaccines & Immunotherapeutics BIOTECHNOLOGY & APPLIED MICROBIOLOGY-IMMUNOLOGY
CiteScore
7.90
自引率
8.30%
发文量
489
审稿时长
3-6 weeks
期刊介绍: (formerly Human Vaccines; issn 1554-8619) Vaccine research and development is extending its reach beyond the prevention of bacterial or viral diseases. There are experimental vaccines for immunotherapeutic purposes and for applications outside of infectious diseases, in diverse fields such as cancer, autoimmunity, allergy, Alzheimer’s and addiction. Many of these vaccines and immunotherapeutics should become available in the next two decades, with consequent benefit for human health. Continued advancement in this field will benefit from a forum that can (A) help to promote interest by keeping investigators updated, and (B) enable an exchange of ideas regarding the latest progress in the many topics pertaining to vaccines and immunotherapeutics. Human Vaccines & Immunotherapeutics provides such a forum. It is published monthly in a format that is accessible to a wide international audience in the academic, industrial and public sectors.
期刊最新文献
Wilms' tumor 1 -targeting cancer vaccine: Recent advancements and future perspectives. Toll-like receptor agonists as cancer vaccine adjuvants. Hotspot areas of tetanus-unprotected births and its associated factors in Ethiopia: Spatial analysis of EDHS data. How well does vaccine literacy predict intention to vaccinate and vaccination status? A systematic review and meta-analysis. Hypophysitis after COVID-19 vaccination in a patient with Rathke's cleft cyst: A case report.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1