Bridging the gap: The future of biosimilars regulations.

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
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引用次数: 0

Abstract

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.

缩小差距:生物仿制药法规的未来。
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。
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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.
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