生物类似药在美国的临床开发时间。

Clinical Development Times for Biosimilars in the United States.

机构信息

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.

出版信息

Mayo Clin Proc. 2020 Oct;95(10):2152-2154. doi: 10.1016/j.mayocp.2020.06.039.

DOI:10.1016/j.mayocp.2020.06.039

PMID:33012346

Abstract

Biosimilars are versions of biologic drugs made by different manufacturers that can help lower spending by promoting competition. However, few biosimilars are currently available in the US. To assess the role of testing requirements in this outcome, we investigated clinical development times for 40 biosimilars that initiated phase I testing between 2012 and 2015. We found that most biosimilars underwent phase III testing with an average trial length of 22 months. Of 20 biosimilars that had been approved by October 2019, the median time from initiation of phase I testing to approval was 69.9 months. These findings reveal a high testing bar for approval that likely contributed to limited market entry.

摘要

生物类似药是由不同制造商生产的生物药物版本，可以通过促进竞争来帮助降低支出。然而，目前美国可用的生物类似药很少。为了评估测试要求在这一结果中的作用，我们调查了 2012 年至 2015 年间开始进行 I 期试验的 40 种生物类似药的临床开发时间。我们发现，大多数生物类似药都进行了 III 期试验，平均试验长度为 22 个月。在 2019 年 10 月之前获得批准的 20 种生物类似药中，从 I 期试验开始到批准的中位数时间为 69.9 个月。这些发现揭示了一个很高的批准测试标准，这可能导致市场进入受限。