ABP 798 is a biosimilar candidate to rituximab reference product (RP). This comprehensive analytical similarity assessment was designed to assess the structural and functional similarity of ABP 798, rituximab (US), and rituximab (EU) using sensitive state-of-the-art analytical techniques capable of detecting small differences in product attributes. The similarity assessment was performed to evaluate product quality attributes associated with Fab, Fab/Fc, and Fc domains, including those known to affect the mechanisms of action. ABP 798 has the same amino acid sequence and exhibits similar secondary and tertiary structures, similar glycan and post-translational modification profiles, and biological activities as rituximab RP. There are minor differences in biochemical attributes, which are not considered clinically meaningful. The results of the analytical and functional similarity assessment demonstrate that ABP 798 is highly analytically similar to rituximab RP. These results support the totality of evidence and the scientific justification for extrapolation of ABP 798 to all therapeutic indications approved for rituximab.

ABP 798 是利妥昔单抗参考产品 (RP) 的候选生物仿制药。这种全面的分析相似性评估旨在评估 ABP 798、利妥昔单抗（美国）和利妥昔单抗（欧盟）的结构和功能相似性，使用能够检测产品属性微小差异的最先进的敏感分析技术。进行相似性评估是为了评估与 Fab、Fab/Fc 和 Fc 域相关的产品质量属性，包括那些已知会影响作用机制的属性。ABP 798 具有与利妥昔单抗 RP 相同的氨基酸序列，并表现出相似的二级和三级结构、相似的聚糖和翻译后修饰谱以及生物活性。生化属性存在细微差异，不具有临床意义。分析和功能相似性评估的结果表明 ABP 798 在分析上与利妥昔单抗 RP 高度相似。这些结果支持将 ABP 798 外推到所有批准用于利妥昔单抗的治疗适应症的全部证据和科学依据。