美国授权的仿制药:流行,特征和时间,2010-19
Annabelle C Fowler1, Ruben Jacobo-Rubio2, Jing Xu3
1Annabelle C. Fowler, Charles River Associates, Boston, Massachusetts.
Health affairs (Project Hope)
|August 7, 2023
概括
经授权的仿制药,即品牌药物的非品牌版本,在2010-2019年期间在美国出现了854次推出. 许多推出战略性地与通用竞争或独家期相吻合.
科学领域:
- 制药经济学 制药经济学
- 药品市场分析 药品市场分析
背景情况:
- 授权仿制药是品牌药物的非品牌版本,由原始制造商或许可人批准和销售.
- 它们的市场进入趋势,与传统仿制药相比的时间以及对竞争的影响在美国仍未得到充分研究.
研究的目的:
- 调查2010年至2019年美国授权仿制药的推出趋势和市场进入时间.
- 分析授权仿制药的战略定位,与传统仿制药推出和独家期相比.
主要方法:
- 利用了来自美国食品和药物管理局 (FDA) 和IQVIA的相关数据.
- 分析了2010年至2019年期间新推出的授权仿制药.
主要成果:
- 在研究期间确定了854个授权的仿制品发布,其中2014年达到峰值.
- 观察到的战略推出模式:75%是在传统的仿制药竞争开始后推出,70%是在180天的仿制药独家期之前或期间推出.
结论:
- 授权的仿制药推出具有战略性时机,通常与传统仿制药或独家窗口的进入市场相吻合.
- 研究结果为了解授权仿制药对药物市场竞争,定价和患者获取药物的影响提供了关键的见解.
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