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Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer
Annals of Oncology ( IF 56.7 ) Pub Date : 2017-06-16 , DOI: 10.1093/annonc/mdx303
K. Blackwell , P. Gascon , C.M. Jones , A. Nixon , A. Krendyukov , R. Nakov , Y. Li , N. Harbeck

Following the functional and physicochemical characterization of a proposed biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar safety and efficacy to the reference product in a sensitive patient population.

中文翻译:

两项随机,双盲试验的合并分析,将拟议的生物仿制药LA-EP2006与参比培非司亭用于乳腺癌的比较

在对拟议的生物仿制药进行功能和物理化学表征后,比较临床研究通过在敏感患者群体中证明与参考产品相似的安全性和有效性,有助于确认生物仿制药的相似性。
更新日期:2017-09-18
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