打破障碍:为具有竞争力和负担得起的生物类药物市场进行必要的改革
Eric T Roberts1, Jinoos Yazdany2,3
1Division of Rheumatology, Department of Medicine, University of California, San Francisco, USA. Eric.roberts@ucsf.edu.
Current rheumatology reports
|May 28, 2025
概括
生物仿制药是安全有效的,通过真实世界的数据得到证实. 政策变化是必要的,以克服障碍,并促进竞争,以降低药物成本.
科学领域:
- 药物经济学 药物经济学
- 卫生政策 卫生政策
- 药物开发 药物开发
背景情况:
- 生物仿制药提供潜在的成本节约和增加患者获得生物疗法的机会.
- 生物价格竞争和创新法 (BPCIA) 的目的是促进具有竞争力的生物类似药市场.
- 类风湿性关节炎治疗领域包括几种已批准的生物类似药.
研究的目的:
- 检查生物类似药的当前政策格局,重点关注类风湿性关节炎治疗.
- 审查最近的文献,并推政策,使生物类似药市场与BPCIA目标保持一致.
- 分析生物类似药物的安全性,有效性,可互换性和市场动态的证据.
主要方法:
- 关于生物类似药物的安全性,有效性和市场动态的最新研究的文献综述.
- 对FDA关于生物类似药物互换性指导的分析.
- 检查反竞争行为,监管挑战和金融激励措施.
主要成果:
- 现实世界的证据证实了生物类似药的安全性和有效性,包括在改变疗法的患者中.
- 美国食品和药物管理局更新的可互换性指导可能会加强基于价格的竞争.
- 仍然存在重大障碍,包括反竞争行为和错误的金融激励措施.
结论:
- 实现BPCIA的目标需要解决专利漏洞,PBM实践和补偿政策.
- 政策调整对于可持续的生物类药物市场至关重要,这将减少药物支出.
- 加强患者与医生的沟通和数据传播是增加生物类似药的吸收的关键.
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