分析数据和单剂量PK足以结论生物类似药的可比免疫性:乌斯特基努马布病例研究
Martin Schiestl1, Nivedita Roy2, Michael Trieb3
1Sandoz GmbH, Kundl, Austria. martin.schiestl@sandoz.com.
概括
临床的药理动力学研究有效地证实了乌斯特基努马布生物类似剂的可比免疫性. 分析数据和PK研究,而不是临床疗效,足以进行生物类似药的免疫性评估.
科学领域:
- 生物制品和生物类似药物
- 免疫学和药物开发
- 监管科学是一种监管科学.
背景情况:
- 生物类似的开发需要证明与参考产品相比的免疫性.
- 分析和临床数据至关重要,特别是当临床疗效研究被遗漏时.
- 乌斯特基努马布生物类似药及其参考产品免疫性需要进行彻底评估.
研究的目的:
- 审查分析和临床数据在评估ustekinumab生物类似药的免疫性方面的作用.
- 评估临床药理动力学 (PK) 研究对生物类似药的免疫性结论的充分性.
- 确定比较性临床疗效研究是否提供了额外的免疫原性见解.
主要方法:
- 对EMA和FDA批准的ustekinumab生物仿制药的公开数据的案例研究审查.
- 临床药理动力学 (PK) 和比较临床疗效研究数据的分析.
- 对抗药物抗体和中和抗体率的评估,以及糖分析.
主要成果:
- 单剂量临床PK研究在检测生物类似药和参考产品之间的免疫性差异方面很敏感.
- 观察到抗药物和中和抗体的比率相似,生物类似剂的数量较低.
- 潜在的免疫原性非人类甘氨酸的较低水平 (例如,α-1,3银河糖) 与生物类似性资料相关.
- 比较的临床疗效研究除了PK和分析数据之外,没有提供额外的免疫原性信息.
结论:
- 单剂量临床PK研究足以证实ustekinumab生物类似剂的可比免疫性.
- 比较分析评估,重点关注具有免疫相关性的质量属性,是关键.
- 临床PK和分析数据足以评估生物类似药的免疫性,简化开发.
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