基于质量属性可比性评估，关于已批准静脉注射免疫球蛋白（IVIg）产品适应症外推的新日本监管观点

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals Pub Date : 2025-09-13 DOI:10.1016/j.biologicals.2025.101860

Takashi Kameda , Kazuki Nagashima , Shun Masuta , Teruhide Yamaguchi , Michihiro Ogawa

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引用次数: 0

摘要

静脉注射免疫球蛋白（IVIg）产品是一种汇集的人血浆来源的IgG药物产品，适用于各种免疫缺陷和自身免疫性疾病。这些适应症在日本基本上是基于对每种产品的临床评估而获得批准的，但IVIg产品的统一或标准化将会有所帮助。我们介绍了一种新的日本监管观点，即基于考虑作用方式（MOA）、质量可比性分析和上市后临床记录对产品有效性和安全性的重新审查，从由完整IgG（化学未修饰的全长IgG）组成的参考产品推断已批准的IVIg产品的适应症。

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A new Japanese regulatory perspective regarding the indication extrapolation between approved intravenous immunoglobulins (IVIg) products based on comparability assessments of quality attributes

Intravenous immunoglobulin (IVIg) product is a pooled human plasma-derived IgG medicinal product indicated for various immunodeficiency and autoimmune diseases. These indications have essentially been approved in Japan based on clinical evaluations of each product, but a harmonization or standardization of IVIg products would be helpful. We introduce a new Japanese regulatory perspective on the extrapolation of indications for approved IVIg products from a reference product composed of intact IgG (chemically unmodified full-length IgG) based on the consideration of the mode of action (MOA), a quality-comparability analysis, and the post-marketing clinical track record's re-examination regarding the products' efficacy and safety.

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来源期刊

Biologicals 生物-生化研究方法

CiteScore

3.70

自引率

0.00%

发文量

审稿时长

48 days

期刊介绍： Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.