PDF(Pubmed)
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.
摘要：
生物类似疫苗和免疫治疗是医学研究中的创新方法。本评论解决了不同国家目前在生物仿制药疫苗和免疫治疗产品法规方面的差异。它还导航全球监管协调的好处和可能遇到的挑战。目前不同国家的法规差异，这对生物仿制药疫苗和免疫治疗产品的开发和批准构成了重大挑战。这些差距往往导致市场准入延迟，增加开发成本，阻碍了创新。评注强调，这些障碍可以通过统一的条例来缓解，导致更快的批准，降低医疗成本，改善患者预后。此外，评论探讨了与生物仿制药疫苗和免疫治疗相关的特定复杂性，例如由于其分子组成和免疫原性特性而对生物相似性进行的复杂评估。总之,社论主张共同努力，克服在实现生物仿制药全球监管协调方面的挑战。这包括建立统一标准，促进监管机构之间的国际合作，并促进医疗保健提供者和监管机构的教育举措。最终目标是确保全世界的患者能够及时获得安全、有效,和负担得起的生物类似疗法。
