生物仿制药:统一审批指南

Sarfaraz K Niazi
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引用次数: 7

摘要

生物仿制药审批指南需要合理化和协调,以消除不一致和误解,从而实现更快、更安全、更具成本效益的生物仿制药。本文基于对美国、英国和欧盟批准的130多种产品以及世卫组织成员国批准的数百种产品的监管文件的科学评估,提出了一个示范指南的平台。对已发表和报告的临床数据的广泛文献调查,包括Clinicaltrials.gov,对美国、英国和欧盟以及世卫组织所有现行指南的审查,以及与FDA的详细讨论,已经证实,取消动物和临床疗效测试并确定其他次要方法将能够创建最适合ICH指定的统一指南。
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Biosimilars: Harmonizing the Approval Guidelines
Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars. This paper proposes a platform for a model guideline based on the scientific evaluation of the regulatory filings of the 130+ products approved in the US, UK, and EU and hundreds more in the WHO member countries. Extensive literature survey of clinical data published and reported, including Clinicaltrials.gov, a review of all current guidelines in the US, UK and EU, and WHO, and detailed discussions with the FDA have confirmed that removing the animal and clinical efficacy testing and fixing other minor approaches will enable the creation of a harmonized guideline that will best suit an ICH designation.
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