A "biosimilar" is a biotechnological product with a lower cost profile and equivalent efficacy and safety to the originator, but post-marketing clinical evaluation of biosimilar products has not been adequately conducted. We prospectively investigated the utility of biosimilar filgrastim in 13 peripheral blood stem cell (PBSC) donors from June 2014 to January 2017. In addition, we retrospectively compared these to another 13 PBSC donors mobilized with the originator filgrastim in the same period. Donor characteristics were equivalent between the groups. The median number of CD34+ cells per donor body weight (BW) and blood volume processed (BV) were 4.87 × 106/kg and 25.5 × 103/mL in the biosimilar group and 4.93 × 106/kg and 16.6 × 103/mL in the originator group, respectively. There were no significant differences between the groups in the number of CD34+ cells per donor BW or BV. All adverse events associated with G-CSF were permissive. The total G-CSF cost was significantly lower in the biosimilar group than in the originator group. These findings suggest that biosimilar filgrastim has the same efficacy and short-term safety as originator filgrastim for PBSC mobilization in healthy donors, with economic superiority. Longer follow-up studies are needed to evaluate the incidence of long-term adverse events.

中文翻译：

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对日本健康捐献者中外周血干细胞动员的生物类似粒细胞集落刺激因子的评估：一项前瞻性研究。

“生物仿制药”是一种生物技术产品，具有较低的成本特征，并且具有与原始产品相同的功效和安全性，但是尚未对生物仿制药进行上市后临床评估。我们从2014年6月至2017年1月前瞻性地研究了仿制药非格司亭在13个外周血干细胞（PBSC）供体中的效用。此外，我们将这些仿制药与同期使用始发非格司亭动员的另外13个PBSC供体进行了比较。各组之间的捐助者特征是相同的。生物仿制药组每供体体重（BW）和已处理血量（BV）的CD34 +细胞中位数为4.87×106 / kg和25.5×103 / mL，而在仿制药组中为4.93×106 / kg和16.6×103 / mL。发起者组。两组之间每个供体BW或BV的CD34 +细胞数量没有显着差异。与G-CSF相关的所有不良事件都是允许的。生物仿制药组的总G-CSF成本明显低于发起者组。这些发现表明，在健康供体中，生物仿制药非格司亭具有与原始非格司亭相同的疗效和短期安全性，具有经济优势。需要更长的随访研究来评估长期不良事件的发生率。这些发现表明，在健康供体中，生物仿制药非格司亭具有与原发性非格司亭相同的功效和短期安全性，具有经济优势。需要更长的随访研究来评估长期不良事件的发生率。这些发现表明，在健康供体中，生物仿制药非格司亭具有与原发性非格司亭相同的功效和短期安全性，具有经济优势。需要更长的随访研究来评估长期不良事件的发生率。