通过应用当前科学和现有证据,生物类似开发的未来演变:开发者的视角
Hillel P Cohen1, Matthew Turner2, Dorothy McCabe3
1Sandoz Inc., Princeton, NJ, USA. hillel.cohen@sandoz.com.
概括
简化生物仿制药批准流程可以提高患者获得负担得起的生物疗法的机会. 消除冗余的临床试验和重新考虑可互换性要求将在不影响安全性或有效性的情况下加速开发.
科学领域:
- 药物经济学 药物经济学
- 监管科学 监管科学
- 生物制药开发 生物制药开发
背景情况:
- 生物类似药在欧洲近二十年,在美国十多年来一直在使用,改善了医疗保健的获取和负担能力.
- 尽管生物疗法已经建立,但在某些市场,患者获得生物疗法仍然是一个挑战.
- 有一个公认的需要优化生物类似药的开发途径,而不会影响质量,安全性或疗效.
研究的目的:
- 在生物类似药物批准过程中识别潜在的效率.
- 建议对临床试验要求和生物类似药的监管名称进行修订.
- 倡导简化开发,以增加各种生物药物的可用性.
主要方法:
- 在生物类似评估中分析不同类型数据的实用性 (生物化学,生物物理,功能测定与临床疗效终点).
- 评估免疫性研究和可互换性指定多个开关研究的监管价值.
- 考虑全球批准标准,制造变化监测和现实世界的证据的作用.
主要成果:
- 生物化学,生物物理和功能分析是生物相似性比临床疗效终点更敏感的指标.
- 额外的临床疗效研究和大型免疫原性研究具有有限的监管价值.
- 对于美国可互换性指标的多个开关研究和欧盟和美国参考产品之间的比较药理动力学测试是不必要的.
结论:
- 应通过减少冗余的临床试验来简化生物类似药的监管途径.
- 互换性要求,特别是多个开关的研究,应该重新考虑和可能消除.
- 利用现实世界的证据和优化审批流程将加速更多生物类似药的开发,提高患者的获取和负担能力.
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