专利申请范围和生物仿制药在美国和欧盟的竞争
Doni Bloomfield1, Aaron S Kesselheim2
1FORDHAM LAW SCHOOL, NEW YORK CITY, NEW YORK, USA.
概括
美国在生物类似药竞争中面临挑战,导致生物药物成本上升. 批准后生物类似药的延迟可用性有助于这一显著的"生物类似药差距".
科学领域:
- 药物经济学 药物经济学
- 卫生政策 卫生政策
- 生物技术是生物技术.
背景情况:
- 美国市场在生物制剂的竞争中扎,与小分子药物不同,仿制药导致价格下降.
- 为了促进竞争,国会于2010年制定了一条简化生物类似药批准的途径.
- 美国生物类似药的市场透率落后于欧洲国家,影响了药品的价格和可获得性.
研究的目的:
- 与欧洲市场相比,分析导致美国生物类似药竞争较弱的因素.
- 调查生物类似药物在美国批准和进入市场之间延迟的原因.
- 了解有限的生物类似药竞争对美国药品总体开支的影响.
主要方法:
- 在美国和欧洲国家之间对生物类似药的可用性和进入市场的时间表进行比较分析.
- 审查监管途径和市场动态,影响生物类似药的吸收.
- 检查美国药物支出数据和生物制品分配的比例.
主要成果:
- 与欧洲国家相比,美国的可用生物仿制药数量显著减少 (例如,截至2020年8月,美国的15种生物仿制药和德国的52种生物仿制药).
- 美国食品和药物管理局 (FDA) 批准和生物类似药的商业可用性之间存在相当大的延迟,平均为301天,在某些情况下高达21.5年.
- 生物制品占美国药物开支的很大一部分 (2022年为41%) 尽管占处方比例较小 (16%).
结论:
- 美国的"生物相似差距",其特点是批准后推迟进入市场,阻碍了竞争,并导致高昂的生物药物成本.
- 政策或市场干预可能是必要的,以加快生物类似药的可用性和促进价格竞争.
- 解决生物类似药及时进入市场的障碍对于减少美国对生物制剂的医疗保健支出至关重要.
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