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生物类似候选药物ABP 938与阿弗利塞普特参考产品的非临床相似性

Neungseon Seo¹, Scott Kuhns², Dina A Andrews²

¹Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA. neungseon.seo@amgen.com.

Ophthalmology and therapy

|November 6, 2024

概括

ABP 938在体外药理学和体内安全性和药理动力学概况方面与阿弗利伯塞普基准产品相似. 这些非临床发现支持ABP 938作为治疗视网膜疾病的aflibercept生物相似药物.

科学领域:

眼科医生眼科眼科
药理学药理学是指药理学的学科.
免疫学免疫学免疫学

背景情况:

ABP 938是一种拟议的生物类似药物,用于治疗视网膜疾病的抗VEGF疗法aflibercept (Eylea®).
之前的分析研究证实了ABP 938和aflibercept参考产品 (RP) 之间的结构和生物相似性.

研究的目的:

为了评估ABP 938的体外药理学.
评估ABP 938与aflibercept RP相比的体内药理动力学 (PK),毒理动力学 (TK) 和安全性.

主要方法:

在体外:表面等离子体共振 (SPR) 用于目标结合动力学/亲和力;基于细胞的试验用于效应器功能.
在体内:子 (PK) 内 (IVT) 眼部分布研究;Cynomolgus子 (TK/安全性) 的1个月IVT毒理学研究.

主要成果:

ABP 938的结合动力学和对VEGF-A和PlGF异型的亲和力与阿弗利塞普RP相似.
在子中,在ABP 938和aflibercept RP之间没有观察到眼部分布动力学的显著差异.
子中的毒理学研究没有显示ABP 938的眼睛或全身毒性,具有与aflibercept RP相似的TK和毒理学概况.

结论:

综合非临床数据支持ABP 938与aflibercept RP的生物相似性.
在体外和体外评估证实了可比的药理学和安全性.

关键词:

ABP 93838 ABP 93838 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 一个自由的概念.生物类似药物制品生物类似药物制品眼部疾病眼部疾病非临床相似性非临床相似性药理动力学药理动力学药理学药理学是指药理学的学科.毒理学毒理学毒理学

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