生物仿制药:一些当前的全球监管框架的方法。

IF 3.2 Q2 Pharmacology, Toxicology and Pharmaceutics

Current clinical pharmacology Pub Date : 2019-01-01 DOI:10.2174/1574884713666181025142928

Efraín Esteban, Rosa-Helena Bustos, Julio-César García, Edwin Jáuregui

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引用次数: 2

摘要

开发新的生物制剂已经导致了旨在保证其安全性、质量和有效性的法规和规范，包括在销售、处方、使用、互换性和转换方面。生物制剂在治疗风湿性、自身免疫性、炎症性和肿瘤性疾病方面具有重要意义。参考生物制剂或发起人专利的到期/失效意味着开发生物仿制药涉及在世界各国批准其相关的法律要求。因此，本文探讨了世界范围内生物类似药的监管情况、相关的技术概念和一些感兴趣的国家的监管差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Biosimilars: An Approach to some Current Worldwide Regulation Frameworks.

Developing new biologics has led to regulations and norms aimed at guaranteeing their safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability and switching. Biologics are of great importance in treating patients suffering from rheumatic, autoimmune, inflammatory and neoplastic diseases. The expiry/lapse of reference biologics or originators' patents has meant that developing biosimilars involves accompanying legal requirements for their approval in countries worldwide. This paper has thus approached the situation of biosimilar regulation worldwide, the pertinent technical concepts and regulatory differences in some countries of interest.

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来源期刊

Current clinical pharmacology PHARMACOLOGY & PHARMACY-

CiteScore

3.60

自引率

0.00%

发文量

期刊介绍： Current Clinical Pharmacology publishes frontier reviews on all the latest advances in clinical pharmacology. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: pharmacokinetics; therapeutic trials; adverse drug reactions; drug interactions; drug metabolism; pharmacoepidemiology; and drug development. The journal is essential reading for all researchers in clinical pharmacology.