从一个营销许可持有者获得的多种生物仿制药的长期真实世界后审批安全数据,自首次生物仿制药推出以来超过18年
Sreedhar Sagi1, Pradeep Anjaneya2, Sameer Kalsekar3
1Sandoz International GmbH, Holzkirchen, Germany. sreedhar.sagi@sandoz.com.
Drug safety
|October 30, 2023
概括
这份对八种桑多斯生物仿制药的综述显示了有利的长期安全性概况,现实数据超过13亿个患者治疗日. 患者和医疗保健提供者可以相信Sandoz生物仿制药与参考生物药物一样安全.
科学领域:
- 药物监督 药物监督 药物监督
- 生物制药安全性 生物制药安全性
- 监管科学是一种监管科学.
背景情况:
- 生物类药物是根据与参考生物制品的分析和临床比较来批准的.
- 尽管最初获得批准,但对生物类似药物长期安全性的担忧仍然存在.
- 这项研究检查了八种桑多斯生物类似药的真实后审批安全数据.
研究的目的:
- 总结八种在市场上销售的桑多斯生物仿制药的现实安全经验.
- 根据药监数据评估生物仿制药的长期安全性概况.
- 解决关于生物类似药的安全性的持续担忧.
主要方法:
- 对八种桑多斯生物类似药的定期安全更新报告 (PSUR) 的批准后药监数据的审查.
- 截至2023年1月31日收集的数据,涵盖最多18年的批准后经验.
- 暴露量以患者治疗日 (PTD) 和患者剂量 (PD) 计算,用于Rituximab.
主要成果:
- 七种生物类似药的联合暴露超过了13亿PTD,而rituximab的联合暴露超过了180万PD.
- 对PSUR累计安全数据的分析表明,所有八种生物类似药的益处风险概况都有利.
- 安全性概况与各自的参考生物相一致.
结论:
- 这次审查是对单个营销许可持有者的批准后生物类似药物监测数据进行的最大分析之一.
- 长达18年的真实世界数据表明,桑多斯生物仿制药与其参考生物药物一样安全.
- 这些发现支持对Sandoz生物类似药的临床益处和安全性以及生物相似性更广泛的概念的信心.
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