相关实验视频

Updated: Jan 15, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

生物类似的Aflibercept SDZ-AFL的开发

Francis Dodeller¹, Peter Alliger², Jens Heyn¹

¹HEXAL AG, Holzkirchen, Germany.

Current therapeutic research, clinical and experimental

|October 10, 2025

概括

桑多斯生物类似的aflibercept (SDZ-AFL) 在有效性,安全性和免疫性方面与参考aflibercept (Ref-AFL) 非常相似. 这种新的生物仿制药有可能改善患者获得重要视网膜疾病治疗的机会.

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.
生物技术是生物技术.

背景情况:

阿弗利塞普特 (Ref-AFL) 是治疗视网膜疾病的关键生物疗法,如新血管与年龄相关的黄斑变性 (nAMD).
生物制剂的高成本可能会限制患者获得基本治疗的机会.
生物类似的开发旨在提供具有可比治疗特征的更实惠的替代品.

研究的目的:

为了评估Sandoz生物相似aflibercept (SDZ-AFL) 与参考aflibercept (Ref-AFL) 的生物相似性.
总结了支持SDZ-AFL作为生物类似药的批准的全面数据包.

主要方法:

SDZ-AFL和Ref-AFL的物理化学和生物特征.
在体外研究评估结构同质性和生物活性.
在子中进行的眼睛药理动力学研究和在nAMD患者中进行的III期临床试验.

主要成果:

与Ref-AFL相比,SDZ-AFL表现出结构同质性和非常相似的体外生物活动.
在SDZ-AFL和Ref-AFL之间,眼部和全身的药物动力学概况是可比的.
第三阶段试验显示了可比的疗效,安全性和免疫性,满足视力敏度的生物等价性标准.

结论:

所有的证据都证实了SDZ-AFL和Ref-AFL之间的生物相似性.
预计SDZ-AFL将提高患者获得视网膜疾病aflibercept治疗的机会.
亚菲利塞普特生物类似药的可用性可能会降低治疗障碍,并扩大患者的益处.

关键词:

一个自由的概念.生物类似物是什么意思神经血管与年龄相关的黄斑变性.视网膜疾病视网膜疾病 SOK583A1 一个问题.

更多相关视频

Author Spotlight: Magnetic Fluorescent Bead-Based Dual-Reporter Flow Analysis of PDL1-Vaxx Peptide Vaccine-Induced Antibody Blockade of the PD-1/PD-L1 Interaction

Author Spotlight: Magnetic Fluorescent Bead-Based Dual-Reporter Flow Analysis of PDL1-Vaxx Peptide Vaccine-Induced Antibody Blockade of the PD-1/PD-L1 Interaction

Published on: July 7, 2023

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

相关概念视频

Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

Bioequivalence: Overview

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...

Bioequivalence studies: Biowaivers

Bioequivalence studies: Biowaivers

Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...