展示 Stimufend（培非格司亭-fpgk）与 Neulasta（培非格司亭）在理化性质和功能方面的相似性：一项比较分析评估。

BACKGROUND

Pegfilgrastim is a long-acting recombinant human granulocyte colony-stimulating factor biologic that is indicated to reduce the incidence of infections, manifested by febrile neutropenia, in patients receiving myelosuppressive anti-cancer drugs and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Due to the high cost of biologic therapy and the scarcity of biosimilar alternatives, there is an unmet medical need for targeted biologics.

OBJECTIVE

This comparative analytical investigation aimed to confirm the similarity of biosimilar Stimufend® (pegfilgrastim-fpgk) to reference product Neulasta® (pegfilgrastim).

METHODS

The analysis was designed using state-of-the-art orthogonal techniques and side-by-side testing to compare the physicochemical and biological properties of these two products. The measured quality attributes included the primary structure and higher order structure of the molecule, purity/impurity profiles, product variants, process-related impurities, composition, content, and biological activity. The statistical analysis was based on risk ranking of the critical quality attributes (very low, low, moderate, high, very high), and scientific considerations in combination with the characteristics of the assay (sensitivity, selectivity, and variability). In addition, non-quantitative parameters were compared using a descriptive assessment of the product profile. Analytical similarity was concluded by quality attributes falling within the defined range of the originator product.

RESULTS

The results of this study confirm that Stimufend® is biosimilar to Neulasta® for all measured quality attributes. There are no clinically significant differences between Stimufend® and Neulasta®, which was confirmed by the marketing approval for Stimufend® by the Food and Drug Administration and the European Medicines Agency.

CONCLUSION

The findings of this study provide robust evidence supporting the structural and functional biosimilarity between Stimufend® and Neulasta®.

背景

培非格司亭是一种长效重组人粒细胞集落刺激因子生物制剂，用于降低接受骨髓抑制性抗癌药物治疗的患者发生感染（表现为发热性中性粒细胞减少症）的发生率，并增加急性暴露于骨髓抑制剂量辐射的患者的存活率。由于生物治疗的高成本和生物类似药替代品的稀缺，存在针对靶向生物制剂的未满足的医疗需求。

目的

本比较分析研究旨在确认生物类似药 Stimufend®（培非格司亭-fpgk）与参比产品 Neulasta®（培非格司亭）的相似性。

方法

该分析采用最先进的正交技术和并排测试设计，比较这两种产品的理化和生物学特性。测量的质量属性包括分子的一级结构和高级结构、纯度/杂质谱、产品变体、与工艺相关的杂质、组成、含量和生物学活性。统计分析基于关键质量属性（极低、低、中、高、极高）的风险分级，以及科学考虑因素与测定法（灵敏度、选择性和变异性）的特点相结合。此外，使用产品概况的描述性评估来比较非定量参数。通过将质量属性落在参比产品定义范围内来推断分析相似性。