关于SDZ-deno的全部证据:与参考denosumab生物相似的生物相似物
Barbara Vogg1, Johann Poetzl1, Arnd Schwebig1
1Hexal AG (a Sandoz company), Holzkirchen, Germany.
Clinical therapeutics
|September 18, 2024
概括
桑多斯生物仿制代诺苏玛布 (Jubbonti/Wyost) 显示了与参考代诺苏玛布 (Prolia/Xgeva) 的分析,临床和疗效等效. 这种生物类似药物有望改善患者获得骨损失治疗的机会.
科学领域:
- 生物制药产品 生物制药产品
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 参考denosumab (REF-deno) 是一种针对RANKL的单克隆抗体,对于控制骨质疏松症等疾病的骨质再吸收至关重要.
- 桑多斯生物类似代诺苏马布 (SDZ-deno) 已获得监管部门对所有REF-deno的指示的批准.
研究的目的:
- 审查支持批准桑多斯生物类似代诺苏马布 (SDZ-deno) 的全部证据.
- 为了确认SDZ-deno与参考denosumab (REF-deno) 的生物相似性.
主要方法:
- 分析研究评估了结构同质性,结合亲和力和免疫性.
- 临床试验 (I期和III期) 评估了健康参与者和患有骨质疏松症的绝经后妇女的药理动力学 (PK),药理动力学 (PD) 和疗效.
主要成果:
- SDZ-deno表现出高纯度和与REF-deno的结构相似性.
- 在等效率范围内,PK和PD参数在SDZ-deno和REF-deno之间是可比的.
- 绝经后骨质疏松症的疗效与REF-deno相似,与骨矿物质密度反应相似.
结论:
- 所有的证据都支持SDZ-deno与REF-deno在所有已批准的适用情况中的生物相似性.
- 预计SDZ-deno是一种有效的治疗选择,由于成本较低,可能会增加患者的治疗机会.
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