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FDA批准Releuko(filgrastim-ayow) ，第三种非格司亭生物仿制药

2022-03-19 网络 网络

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2022年2月28日，美国食品药品监督管理局(FDA)已批准Releuko (filgrastim-ayow)，一种与Neupogen (filgrastim，非格司亭)相似的生物制剂。

2022年2月28日，美国食品药品监督管理局(FDA)已批准Releuko (filgrastim-ayow)，一种与Neupogen (filgrastim，非格司亭)相似的生物制剂。

FDA批准是基于对数据的审查，这些数据表明Releuko与其参考药物Neupogen具有高度相似性。

在美国，Releuko适用于：

· 降低接受骨髓抑制抗癌药物治疗的非髓性恶性肿瘤患者中感染的发生率(表现为发热性中性粒细胞减少症)，这与发热性严重中性粒细胞减少症的发生率显著相关。

· 在急性髓性白血病(AML)患者接受诱导或巩固化疗治疗后，缩短中性粒细胞恢复时间和发热持续时间。

· 在接受清髓性化疗并随后进行骨髓移植的非髓性恶性肿瘤患者中，缩短中性粒细胞减少症和中性粒细胞减少症相关临床后遗症(例如发热性中性粒细胞减少症)的持续时间(BMT)。

· 降低有症状的先天性嗜中性粒细胞减少症、环状嗜中性粒细胞减少症或特发性嗜中性粒细胞减少症患者中严重嗜中性粒细胞减少症后遗症(如发热、感染、口咽溃疡)的发生率和持续时间。

Releuko (filgrastim-ayow)是继Zarxio (filgrastim-sndz)和Nivestym (filgrastim-aafi)之后，第三种获得FDA批准的Neupogen生物仿制药。

参考资料：

https://www.empr.com/home/news/biosimilar-releuko-gets-fda-approval/

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    2022-07-16 bugit

    #FDA批准#

    0

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    2022-10-19 heli0118

    #AST#

    0

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    2022-03-21 drwjr

    #仿制药#

    0

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    2022-03-21 grace5701

    #生物仿制药#

    0