Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea^®).

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-08-01 Epub Date: 2024-06-15 DOI:10.1007/s40123-024-00977-0

Hangyeore Lee, Jongcheol Huh, Dayoung Kim, Soye Lee, Jaeil Lee, Jungmin Lee, Beom Chan Kim, Jinsu Song

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引用次数: 0

Abstract

Introduction: SB15 is a proposed biosimilar product of reference aflibercept (Eylea^®), an approved biological drug product for retinal diseases including neovascular age-related macular degeneration (nAMD). This study aimed to assess the analytical similarity between SB15 and its commercially available reference product (RP) sourced from the United States (US-aflibercept) and European Union (EU-aflibercept) in terms of structural, physicochemical, and biological properties.

Methods: A panel of state-of-the-art analytical methods was used for the comprehensive characterization of SB15 and US/EU-aflibercept. In terms of the structural and physicochemical properties, primary structure; post-translational modifications (PTM); higher-order structure; purity and impurities; charge variants; and glycosylation were compared. In addition, biological characterization including mechanism of action (MoA)-related and Fc-related biological activities was conducted.

Results: Analytical similarity between SB15 and US/EU-aflibercept was demonstrated. The primary and higher-order structure of SB15 was confirmed to be comparable to that of US/EU-aflibercept. In addition, there were no meaningful differences in the physicochemical properties in terms of size and charge heterogeneity between SB15 and its RP. SB15 and RP were similar in biological activities including MoA-related binding activities, potencies, and Fc-related biological functions. Consequently, SB15 was confirmed to be highly similar to US/EU-aflibercept.

Conclusions: Based on a comprehensive analytical similarity assessment of structural, physicochemical, and biological properties, SB15 was demonstrated to be highly similar to US/EU-aflibercept RP, supporting safe and effective use of SB15.

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用于评估阿非利贝拉西普生物仿制药 SB15 与参考产品 (Eylea®) 相似性的分析表征。

简介：SB15是阿弗利百普（Eylea®）的拟生物类似药，阿弗利百普是一种已获批准的治疗视网膜疾病（包括新生血管性年龄相关性黄斑变性（nAMD））的生物药。本研究旨在评估SB15与其来自美国（US-aflibercept）和欧盟（EU-aflibercept）的市售参比产品（RP）在结构、理化和生物特性方面的分析相似性：采用一组最先进的分析方法对 SB15 和美国/欧盟-阿夫利拜因进行了综合表征。在结构和理化特性方面，比较了一级结构、翻译后修饰（PTM）、高阶结构、纯度和杂质、电荷变异和糖基化。此外，还进行了生物学特性分析，包括与作用机制（MoA）相关的生物活性和与 Fc 相关的生物活性：结果：SB15与US/EU-aflibercept之间的分析相似。经证实，SB15的一级结构和高阶结构与US/EU-aflibercept相似。此外，SB15 与其 RP 在大小和电荷异质性方面的理化性质没有明显差异。SB15 和 RP 的生物活性相似，包括与 MoA 相关的结合活性、效力和与 Fc 相关的生物功能。因此，SB15 被证实与 US/EU-aflibercept 高度相似：基于结构、理化和生物学特性的综合分析相似性评估，SB15被证实与US/EU-aflibercept RP高度相似，支持安全有效地使用SB15。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. 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