丹诺苏玛布生物类似物MB09和参考丹诺苏玛布的群体PK建模以确定PK相似性
Sara Sánchez-Vidaurre1, Alexandra Paravisini1, Javier Queiruga-Parada1
1Medical Department, mAbxience Research S.L., 28050 Madrid, Spain.
Pharmaceutics
|September 27, 2025
概括
这种种群体的药理动力学元分析证实MB09,一个denosumab生物类似物,表现出与参考产品Xgeva和Prolia相似的药理动力学特征,支持其生物相似性. 这项研究的特点是denosumab.
科学领域:
- 药理动力学和药理动力学
- 生物药物和生物类似药物
- 临床药理学 临床药理学
背景情况:
- MB09是一种denosumab生物类似剂.
- 参考产品是Xgeva和Prolia. 这两种药物是最常见的.
- 进行了人口药理动力学 (popPK) 分析.
研究的目的:
- 描述德诺苏马布的PK概况.
- 支持MB09生物相似性.
- 将MB09的PK概况与denoSumab的RP概况进行比较.
主要方法:
- 聚合了第一期和第三期研究中的denosumab PK数据.
- 一个隔间模型,具有第一阶吸收/消除和非线性清除.
- 体重和治疗作为共变量;PK生物相似性在35毫克剂量时进行评估.
主要成果:
- 表面清除:0.123 L/天;中央分布体积:9.33 L,70 公斤的受试者.
- 迈克利斯常数:0.124 ng/mL;非线性清除的最大速率:0.139 ng/天.
- 基于模型的生物等价性标准满足了RP Xgeva vs. MB09在60 mg SC;模拟的MB09120 mg SC的AUC与已发表的Xgeva120 mg SC相似.
结论:
- 提供了对代诺苏马布PK特性的有价值评估.
- 埃卢西达斯MB09的PK资料与德诺苏马布RP的比较.
- 支持MB09生物相似性的全部证据.
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