日本的药物损失:新兴生物制药公司开发新药与欧洲的比较分析。

IF 5.5 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Mihoko Kobayashi, Mamoru Narukawa
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引用次数: 0

摘要

新兴生物制药公司是药物开发的关键参与者,处理了一半以上的临床试验。随着日本以外新兴生物制药公司开发新药的增加,在其他国家获得批准的药物没有在国内获得批准或开发的情况已经成为日本的一个问题。由于这些公司中80%的总部不在欧洲,因此欧洲也可能存在药物损失。在本研究中,我们以新兴生物制药公司开发的药物为研究对象,考察了日本与欧洲相比的药物损失状况,以探讨其原因和解决方案。2019年至2023年,在美国获批的98种新兴生物制药企业申报的新药中,日本的药损产品占比52.0%,远高于欧洲的19.4%。在参与美国新药申请/生物制品许可申请的关键研究方面,将日本纳入关键研究的药物数量相当低(16.3%),而将欧洲纳入关键研究的药物数量为73.4%。由于市场吸引力、语言、地理位置和各国特定的监管要求,新兴生物制药公司在欧洲的药物开发比在日本更积极。由于新兴生物制药公司的商业模式与大型制药公司不同,因此有必要采取具体措施改善日本的药品损失状况。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Drug Loss in Japan: A Comparative Analysis with Europe for New Drugs Developed by Emerging Biopharma Companies.

Emerging biopharma companies are key players in drug development, handling more than half of all clinical trials. Drug loss, a situation in which a drug approved in other countries has not been approved nor has its development been initiated at home, has become an issue in Japan following an increase in new drugs developed by emerging biopharma companies outside Japan. As 80% of these companies are not based in Europe, drug loss may also exist in Europe. In this study, we focused on drugs developed by emerging biopharma companies and examined the state of drug loss in Japan compared to Europe to explore the causes and solutions. Of the 98 new drugs approved in the United States between 2019 and 2023 and filed by emerging biopharma companies, drug-loss products in Japan accounted for 52.0%, which is much higher than that in Europe (19.4%). Regarding involvement in the pivotal study of new drug applications/biologics license applications in the United States, the number of drugs that included Japan in the pivotal study was quite low (16.3%), whereas those that included Europe were 73.4%. Emerging biopharma companies have been more aggressive in drug development in Europe than in Japan because of market attractiveness, language, geographical location, and country-specific regulatory requirements. Since emerging biopharma companies have a different business model from large pharmaceutical companies, taking specific measures to improve the state of drug loss in Japan is necessary.

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来源期刊
CiteScore
12.70
自引率
7.50%
发文量
290
审稿时长
2 months
期刊介绍: Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.
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