A white paper: US biosimilars market on pace with Europe

IF 0.3 Q4 PHARMACOLOGY & PHARMACY

GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2020-12-15 DOI:10.5639/GABIJ.2020.0904.025

M. Feldman, M. Reilly

引用次数: 1

Abstract

In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed.

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白皮书:美国生物仿制药市场与欧洲同步

在美国，已有28种生物仿制药获得批准，其中10种是在过去两年获得批准的。美国正在跟上欧盟的步伐，后者在10年前率先批准了生物仿制药。本文讨论了当前FDA法规和美国生物类似药批准和吸收遇到的障碍。

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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来源期刊

GaBI Journal-Generics and Biosimilars Initiative Journal PHARMACOLOGY & PHARMACY-

CiteScore

1.80

自引率

0.00%

发文量

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