对瘤药物的通用可用性的景观分析
Vaibhav Kumar1, Fenggong Wang2, Meng Hu2
1Division of Oncology 3, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Therapeutic innovation & regulatory science
|August 10, 2023
概括
与心血管药物相比,通用瘤药物面临更长的开发时间表. 影响仿制药可用性的关键因素包括药物的复杂性和监管要求,例如为生物等价性研究注册患者.
科学领域:
- 药物经济学 药物经济学
- 药物开发 药物开发
- 瘤学 治疗学 治疗学
背景情况:
- 通用药物开发对于美国负担得起的癌症治疗至关重要.
- 影响通用瘤药物开发的因素与其他治疗领域不同.
- 这项研究比较了瘤学与心血管疾病的通用竞争.
研究的目的:
- 评估影响仿制药在瘤学领域竞争的变量.
- 为了比较类型药物开发时间表之间的瘤和心血管指示.
- 确定与缩写新药申请 (ANDA) 可用性相关的因素.
主要方法:
- 利用FDA和公共数据进行药物批准 (1950-2021年).
- 采用机器学习来识别与ANDA可用性相关的变量.
- 使用卡普兰-梅尔和考克斯回归分析来比较通用药批准的时间.
主要成果:
- 与心血管药物 (80%) 相比,更少的瘤药物 (49%) 有仿制药.
- 瘤药物从参考列表药物 (RLD) 批准到首次ANDA批准的中位时间较长 (15.4年 vs 12.3年).
- 产品剂型和生物等价性 (BE) 研究要求 (例如,患者入学) 与瘤药物的ANDA批准可能性降低有关.
结论:
- 与心血管药物相比,瘤药物的通用可用性时间要长得多.
- 监管建议,特别是生物等价性 (BE) 研究设计,是利益相关方参与的关键领域.
- 了解这些变量可以为改善通用瘤药物开发和患者获取的战略提供信息.
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