导航美国FDA授权的通用药物批准趋势 (2019-2024):提高医疗保健的可访问性和可负担性
M Sowndharya1, Ramesh Joga1, Kajal Gandhi1
1Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, 500037, India.
Therapeutic innovation & regulatory science
|May 22, 2025
概括
授权仿制药 (AG) 在使药物易于获得和负担得起方面发挥着关键作用. 本研究分析了USFDA AG的批准,揭示了治疗领域和关键公司的趋势,突出了它们对医疗保健的影响.
科学领域:
- 制药科学 制药科学
- 卫生经济学 卫生经济学
- 监管事务 监管事务
背景情况:
- 授权仿制药 (AG) 代表了制药市场的关键部分,促进了从品牌药物到仿制药的转变.
- 了解AG批准趋势对于评估其对市场动态,医疗保健成本和患者获取药物的影响至关重要.
研究的目的:
- 分析2019年1月至2024年8月美国食品和药物管理局 (USFDA) 授权的仿制药 (AG) 批准的趋势.
- 确定主要的治疗领域,占主导地位的剂量形式,以及参与AG批准的关键制药公司.
- 通过案例研究,探索市场动态和AGs在提高医疗保健可及性和负担能力方面的作用.
主要方法:
- 来自FDA授权的仿制药名单的数据汇编.
- 分析年度批准趋势,治疗领域和剂量形式.
- 公司对表现最好的公司及其战略重点进行了明智的分析.
- 包括关于AGs临床和经济意义的案例研究.
- 审查立法影响 (通货膨胀减缓法案等) 在AG和制药行业.
主要成果:
- AG批准在2019年 (31%) 和2020年 (33%) 达到顶峰,随后下降.
- 领先的治疗领域包括心血管 (18%),神经学 (14%),内分泌学 (13%).
- 药片 (35%) 和囊 (23%) 是主要的剂型.
- 格拉克索史密斯克莱恩,巴斯奇健康和IBSA制药公司是领先的公司之一.
- 案例研究证实了AG作为糖尿病和心血管疾病等慢性疾病的负担得起的替代品.
结论:
- 经授权的仿制药在将品牌药物与仿制药过渡的桥梁中起着关键作用,提高了治疗准入和成本效益.
- 药品制造商为制药创新做出贡献,同时面临着与传统仿制药的独家性和利率相关的挑战.
- 这些发现强调了AG在推动制药市场动态和提高医疗保健负担能力方面的重要作用.
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