生物仿制药市场:美国和欧盟比较

Pub Date : 2020-06-15 DOI:10.5639/gabij.2020.0902.015

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引用次数: 2

摘要

美国和欧洲监管程序的差异可能导致生物仿制药批准所需时间的差异。在某些情况下，欧洲药品管理局批准生物仿制药的速度更快，欧洲总体上批准的生物仿制药更多，而美国在2015年批准了第一个生物仿制药。无论市场如何，都可以采用许多策略来帮助解决患者和医疗保健提供者的问题，例如教育方案。本文在这些方面提供了一些见解。

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 markets: US and EU compared

Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a number of strategies that can be employed to help address patient and healthcare provider concerns, such as educational programmes. This paper provides some insights on these aspects.

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