Skrlin A, Radic I, Vuletic M, Schwinke D, Runac D, Kusalic T, Paskvan I, Krsic M, Bratos M, Marinc S
Hospira Zagreb d.o.o., Quality Prilaz baruna Filipovica 27/D, 10 000 Zagreb, Croatia.
Biologicals. 2010 Sep;38(5):557-66. doi: 10.1016/j.biologicals.2010.05.002. Epub 2010 Jul 16.
Recombinant human granulocyte-colony stimulating factor (filgrastim) is a therapeutic protein used primarily to reduce incidence and duration of severe neutropenia and its associated, and serious, complications. We have developed a biosimilar filgrastim (Hospira filgrastim; Nivestim) designed to be comparable to Amgen filgrastim (Neupogen). An extensive characterization study assessed the physiochemical similarity of Hospira filgrastim to Amgen filgrastim. Both drugs were supplied in 1 ml glass, single-use, prefilled syringes (five batches of each product at 480 microg/0.5 ml and one batch of each product at 300 microg/0.5 ml). Samples were evaluated using state-of-the-art analytical methods (validated in accordance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use or Pharmeuropa guidelines) to determine physicochemical properties, molecular characteristics, purity and biological activity. Samples were compared after long-term storage at 2-8 degrees C and storage at 40 degrees C (stress conditions) to evaluate their degradation impurity profiles. Hospira filgrastim and Amgen filgrastim were shown to have similar physicochemical properties, molecular characteristics, purity and biological activity. No significant differences in product-related impurities were recorded between Hospira filgrastim and Amgen filgrastim following storage for 12 weeks under stress conditions. These data show that the physicochemical profile of Hospira filgrastim is similar to that of Amgen filgrastim.
重组人粒细胞集落刺激因子（非格司亭）是一种治疗性蛋白质，主要用于降低严重中性粒细胞减少症及其相关严重并发症的发生率和持续时间。我们研发了一种生物类似药非格司亭（辉瑞公司的非格司亭；Nivestim），旨在使其与安进公司的非格司亭（Neupogen）具有可比性。一项广泛的特性研究评估了辉瑞公司非格司亭与安进公司非格司亭的物理化学相似性。两种药物均以1毫升玻璃单剂量预填充注射器提供（每种产品各有五批480微克/0.5毫升以及各有一批300微克/0.5毫升）。使用先进的分析方法（根据人用药品注册技术要求国际协调会议或《欧洲药品质量管理局》指南进行验证）对样品进行评估，以确定其物理化学性质、分子特征、纯度和生物活性。在2至8摄氏度长期储存以及在40摄氏度（加速条件）储存后对样品进行比较，以评估其降解杂质谱。结果显示，辉瑞公司非格司亭与安进公司非格司亭具有相似的物理化学性质、分子特征、纯度和生物活性。在加速条件下储存12周后，辉瑞公司非格司亭与安进公司非格司亭之间未记录到与产品相关杂质的显著差异。这些数据表明，辉瑞公司非格司亭的物理化学特征与安进公司非格司亭相似。
