生物仿制药和安全问题

Advances in Pharmacoepidemiology and Drug Safety Pub Date : 2017-07-19 DOI:10.4172/2167-1052.1000e143

E. Yiannakopoulou

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引用次数: 0

摘要

目前，人们对生物仿制药的开发一直很感兴趣，因为生物仿制药有望导致价格竞争和降低医疗成本。第一种生物仿制药是Omnitrope®，一种重组人生长激素(rhGH)的生物仿制药;2006年在欧洲获得了欧洲药品管理局的批准。从那时起，20种生物仿制药已在欧洲获得批准，包括造血生长因子、胰岛素、单克隆抗体。

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 and Safety Issues

Nowadays there is ongoing interest in the development of biosimilars, as biosimilars are anticipated to lead to price competition and to lower healthcare costs The first biosimilar, Omnitrope®, a biosimilar agent of the Recombinant Human Growth Hormone [rhGH]; was approved in Europe by the European Medicines Agency in 2006. Since then, 20 biosimilars have been approved in Europe including hematopoietic growth factors, insulin, monoclonal antibodies.

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Advances in Pharmacoepidemiology and Drug Safety

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