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2017年及以后抗体治疗药物国际非专利名称的变更:小鼠、人类及其他。

Changes to International Nonproprietary Names for antibody therapeutics 2017 and beyond: of mice, men and more.

作者信息

Parren Paul W H I, Carter Paul J, Plückthun Andreas

机构信息

a The Antibody Society , Framingham , MA , USA.

b Genmab , Utrecht , the Netherlands.

出版信息

MAbs. 2017 Aug/Sep;9(6):898-906. doi: 10.1080/19420862.2017.1341029. Epub 2017 Jun 16.

Abstract

Active pharmaceutical substances require an International Nonproprietary Name (INN) assigned by the World Health Organization (WHO) to obtain market authorization as a medicinal product. INNs are selected to represent a unique, generic name for a drug enabling unambiguous identification by stakeholders worldwide. INNs may be requested after initiating clinical development of an investigational drug. Pharmaceutical classes are indicated by a common stem or suffix. Currently, INNs for monoclonal antibody-based drugs are recognized by the suffix, -mab, preceded by a source infix such as -xi- (chimeric), -zu- (humanized) or -u- (human) designating the species from which the antibody was derived. However, many technological advances have made it increasingly difficult to accurately capture an antibody's source in its name. In 2014, the WHO and the United States Adopted Names (USAN) Council approached this challenge by implementing changes to antibody source infix definitions. Unfortunately, gaps and ambiguities in the definitions and procedures resulted in inconsistent source category assignments and widespread confusion. The Antibody Society, extensively supported by academic and industry scientists, voiced concerns leading to constructive dialog during scheduled consultations with WHO and USAN Council representatives. In June 2017, the WHO announced that use of the source infix will be discontinued for new antibody INNs effective immediately. We fully support this change as it better aligns antibody INNs with current and foreseeable future innovations in antibody therapeutics. Here we review the changes implemented. Additionally, we analyzed antibody INNs recently assigned under the previous 2014 definitions and provide recommendations for further alignment.

摘要

活性药物成分需要有世界卫生组织(WHO)指定的国际非专利名称(INN),才能获得作为药品的市场授权。选择INN是为了代表一种药物的独特通用名称,以便全球利益相关者能够明确识别。在启动研究性药物的临床开发后,可以申请INN。药物类别由共同的词干或后缀表示。目前,基于单克隆抗体的药物的INN通过后缀-mab识别,前面有一个来源中缀,如-xi-(嵌合)、-zu-(人源化)或-u-(人源),表示抗体的来源物种。然而,许多技术进步使得在名称中准确体现抗体的来源变得越来越困难。2014年,WHO和美国采用名称(USAN)委员会通过对抗体来源中缀定义进行修改来应对这一挑战。不幸的是,定义和程序中的差距和模糊性导致来源类别分配不一致,引发了广泛的混乱。在学术和行业科学家的广泛支持下,抗体协会表达了关切,这在与WHO和USAN委员会代表的定期磋商中引发了建设性对话。2017年6月,WHO宣布,对于新的抗体INN,将立即停止使用来源中缀。我们完全支持这一变化,因为它使抗体INN更好地与抗体治疗的当前和可预见的未来创新保持一致。在此,我们回顾已实施的变化。此外,我们分析了最近根据2014年以前的定义指定的抗体INN,并提出了进一步调整的建议。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc36/5590622/3e2a185c0aeb/kmab-09-06-1341029-g001.jpg

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