世界卫生组织国际参考标准在生物仿制药产品生命周期中的重要性

IF 4.1 3区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

Annals of the New York Academy of Sciences Pub Date : 2024-09-10 DOI:10.1111/nyas.15217

Hye‐Na Kang, Meenu Wadhwa, Ivana Knezevic, Chris Burns, Elwyn Griffiths

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引用次数: 0

摘要

分析技术的进步以及过去十年从生物仿制药开发/批准中获得的科学和监管知识与经验，使世界卫生组织（WHO）得以在 2022 年修订其生物仿制药评估指南。在修订内容中，将更多地依赖分析和功能方面来证明相似性（可能会减少临床要求）。世卫组织的生物仿制药国际参考标准为监管机构在质量属性的科学和技术措施方面寻求基于证据和数据的监管趋同提供了更多信心。这些标准可作为统一生物仿制药生物活性或效力的基准，确保其未来的可持续性。本文讨论了世卫组织国际参考标准在生物仿制药整个产品生命周期中的可用性和作用。

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The importance of World Health Organization international reference standards in the product life cycle of biosimilars

Technological advances in analytics, as well as scientific and regulatory knowledge and experience gained from biosimilar development/approvals over the last decade, enabled the World Health Organization (WHO) in 2022 to revise its guidelines on the evaluation of biosimilars. Among the revisions, there is more reliance on analytical and functional aspects to prove similarity (and likely fewer clinical requirements). WHO international reference standards for biosimilars provide additional confidence to regulators looking for evidence‐ and data‐based regulatory convergence in scientific and technical measures of quality attributes. These standards serve as a benchmark for harmonizing the bioactivity or potency of biosimilars, ensuring their future sustainability. This article discusses the availability and role of WHO international reference standards throughout the product life cycle of biosimilars.

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来源期刊

Annals of the New York Academy of Sciences 综合性期刊-综合性期刊

CiteScore

11.00

自引率

1.90%

发文量

193

审稿时长

2-4 weeks

期刊介绍： Published on behalf of the New York Academy of Sciences, Annals of the New York Academy of Sciences provides multidisciplinary perspectives on research of current scientific interest with far-reaching implications for the wider scientific community and society at large. Each special issue assembles the best thinking of key contributors to a field of investigation at a time when emerging developments offer the promise of new insight. Individually themed, Annals special issues stimulate new ways to think about science by providing a neutral forum for discourse—within and across many institutions and fields.