ABP 215 is a biosimilar product to bevacizumab. Bevacizumab acts by binding to vascular endothelial growth factor A, inhibiting endothelial cell proliferation and new blood vessel formation, thereby leading to tumor vasculature normalization. The ABP 215 analytical similarity assessment was designed to assess the structural and functional similarity of ABP 215 and bevacizumab sourced from both the United States (US) and the European Union (EU). Similarity assessment was also made between the US- and EU-sourced bevacizumab to assess the similarity between the two products. The physicochemical properties and structural similarity of ABP 215 and bevacizumab were characterized using sensitive state-of-the-art analytical techniques capable of detecting small differences in product attributes. ABP 215 has the same amino acid sequence and exhibits similar post-translational modification profiles compared to bevacizumab. The functional similarity assessment employed orthogonal assays designed to interrogate all expected biological activities, including those known to affect the mechanisms of action for ABP 215 and bevacizumab. More than 20 batches of bevacizumab (US) and bevacizumab (EU), and 13 batches of ABP 215 representing unique drug substance lots were assessed for similarity. The large dataset allows meaningful comparisons and garners confidence in the overall conclusion for the analytical similarity assessment of ABP 215 to both US- and EU-sourced bevacizumab. The structural and purity attributes, and biological properties of ABP 215 are demonstrated to be highly similar to those of bevacizumab.

ABP 215是贝伐单抗的生物仿制药。贝伐单抗通过与血管内皮生长因子A结合，抑制内皮细胞增殖和新血管形成而起作用，从而导致肿瘤脉管系统正常化。ABP 215分析相似性评估旨在评估源自美国（US）和欧盟（EU）的ABP 215和贝伐单抗的结构和功能相似性。在美国和欧盟采购的贝伐单抗之间也进行了相似性评估，以评估两种产品之间的相似性。ABP 215和贝伐单抗的理化性质和结构相似性使用能够检测产品属性中细微差异的灵敏的最新分析技术进行表征。与贝伐单抗相比，ABP 215具有相同的氨基酸序列，并具有相似的翻译后修饰特性。功能相似性评估采用正交试验设计，旨在询问所有预期的生物学活性，包括已知会影响ABP 215和贝伐单抗作用机制的生物学活性。评估了代表独特药物批次的20批以上贝伐单抗（美国）和贝伐单抗（欧盟）和13批ABP 215的相似性。大型数据集可进行有意义的比较，并使ABP 215与美国和欧盟来源的贝伐单抗的分析相似性评估的总体结论充满信心。已证明ABP 215的结构和纯度属性以及生物学特性与贝伐单抗高度相似。