生物类似药:发展,监管格局和临床影响的批判性审查
Ankit Monga1, Gagan1, Pragya Jamwal1
1School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi, India, 110017.
AAPS PharmSciTech
|January 27, 2025
概括
生物类药物为生物制剂提供了具有成本效益的替代品,需要严格的测试才能获得监管部门的批准. 合作是克服市场准入挑战和增加采用更好的医疗保健结果的关键.
科学领域:
- 生物制药的发展.
- 监管科学是一种监管科学.
- 卫生经济学 卫生经济学
背景情况:
- 生物制药行业正在经历生物类似药开发和批准的显著增长.
- 生物类药物为原始生物制品提供了成本高效的替代品,减轻了医疗保健的财务负担.
- 生物类似制造是复杂的,需要遵守严格的监管标准.
研究的目的:
- 审查生物类似药的监管环境和市场挑战.
- 要突出生物类似药物批准的分析和临床要求.
- 评估生物仿制药对医疗保健成本和患者获取医疗服务的影响.
主要方法:
- 审查来自EMA,世卫组织和美国FDA等机构的监管指南.
- 分析性特征和临床相似性研究 (PK/PD) 的分析.
- 检查案例研究 (利图西马布,阿达利穆马布,菲尔格拉斯蒂姆,特拉斯图扎布) 和市场准入障碍.
主要成果:
- 生物类似药需要大量的分析和临床数据来证明与参考产品的高度相似性.
- 监管机构已经为生物类药物评估和营销后监督制定了明确的指导方针.
- 尽管取得了进展,但互换性和专利保护等挑战仍然阻碍了市场准入和采用.
- 生物类似药的采用导致了显著的成本降低,在美国估计为20-30%.
结论:
- 监管机构,行业和医疗保健提供者之间的协作努力对于加强生物类似药物获取至关重要.
- 增加生物类似药的采用可以改善患者的治疗结果,并推动医疗保健系统的变革性变化.
- 克服市场准入障碍对于实现生物类似药在降低医疗保健成本方面的全部潜力至关重要.
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