仿制药来那度胺的开发故事:一家公司如何挫败《哈奇-瓦克斯曼法案》,创造数十亿美元的收入

IF 2 Q3 HEALTH POLICY & SERVICES Journal of Cancer Policy Pub Date : 2023-09-28 DOI:10.1016/j.jcpo.2023.100446
Ryan J. Beechinor , Ghulam Rehman Mohyuddin , David E. Mitchell , Daniel Aaron , Zahra Mahmoudjafari
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引用次数: 0

摘要

来那度胺(Revlimid®)最初于2005年获得美国食品药品监督管理局(FDA)的批准,但直到2022年才有仿制药版本。在那段时间里,来那度胺的价格上涨了20多倍,仅在2021年就占到了>$58亿美元的医疗保险D部分支出。这是制造商采用法律策略阻碍来那度胺仿制药配方开发的直接后果。在本报告中,我们回顾了来那度胺的临床开发,提供了美国仿制药生产的背景,描述了制造商为防止仿制药来那度酰胺进入美国市场所采取的步骤,并倡导对美国食品药品监督管理局的审批程序和专利法保护进行立法改革。
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The story of the development of generic lenalidomide: How one company thwarted the Hatch-Waxman Act to generate billions of dollars in revenue

Lenalidomide (Revlimid®) was originally approved by the Food and Drug Administration (FDA) in 2005, however, a generic version was not available until 2022. In that time, the price of lenalidomide has increased more than 20 times, and in 2021 alone, it accounted for >$5.8 billion dollars in Medicare Part D spending. This was a direct consequence of legal tactics employed by the manufacturer to thwart development of generic formulations of lenalidomide. In this report, we review the clinical development of lenalidomide, provide background on generic drug manufacturing in the United States (US), describe the steps that the manufacturer took to prevent entry of generic lenalidomide into the US market, and advocate for legislative reform of the FDA approval process and patent law protections in the US.

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来源期刊
Journal of Cancer Policy
Journal of Cancer Policy Medicine-Health Policy
CiteScore
2.40
自引率
7.70%
发文量
47
审稿时长
65 days
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