美国对生物与小分子药物的法律保护差异
Olivier J Wouters1, Matthew Vogel2, William B Feldman3,4
1Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
JAMA
|November 25, 2024
概括
生物制药和小分子药物具有相似的开发时间和成本,但生物制药获得更长的市场独家权. 这表明美国法律可能会过分地奖励生物开发而不是小分子药物.
科学领域:
- 制药和药物开发
- 卫生经济与政策
背景情况:
- 生物药物获得12年的市场独家权,而小分子药物则获得5年的市场独家权,
- 这些不同的法律保护是基于生物制品需要更多的开发时间和资源,并且具有较弱的专利保护.
研究的目的:
- 分析美国关于生物与小分子药物的经验证据.
- 评估生物制剂市场独占权和谈判保护的假设.
主要方法:
- 对开发时间,临床试验成功率,研发成本,专利保护,市场独家权,收入和治疗成本的最新数据进行分析.
- 2009-2023年间美国食品和药物管理局 (FDA) 批准的生物制剂和小分子药物的比较.
主要成果:
- 生物药物和小分子药物具有相似的中位数开发时间 (12.6 vs 12.7 年) 和开发成本 (3.0 亿美元 vs 2.1 亿美元).
- 生物制剂的临床试验成功率更高,专利数量显著增加 (14 vs 3),竞争时间更长 (20.3 vs 12.6年),峰值收入更高 (1.1 亿美元 vs 0.5 亿美元),年治疗成本中位数更高 (92 千美元 vs 33 千美元).
结论:
- 只有有限的证据支持生物制品获得更长的市场独家权和谈判保护期.
- 与小分子药物相比,美国法律似乎不成比例地奖励生物发展,这可能是由于对发展的错误假设.
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