医療薬学
Online ISSN : 1882-1499
Print ISSN : 1346-342X
ISSN-L : 1346-342X
一般論文
悪性リンパ腫におけるフィルグラスチムバイオ後続品「モチダ」と先行バイオ医薬品の前向きランダム化クロスオーバー比較試験
大坪 達弥中川 ゆかり藤田 将輝石田 曜子澤田 真嗣友金 幹視藤田 敦夫魚嶋 伸彦小林 裕三上 正
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2015 年 41 巻 11 号 p. 793-798

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The pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence between the filgrastim biosimilar “Mochida” and filgrastim have been confirmed in clinical pharmacology studies in healthy volunteers. In a phase III breast cancer clinical trial, patients were administered FEC therapy (fluorouracil, epirubicin, cyclophosphamide), but a comparison with filgrastim was not performed. Therefore, we conducted a prospective, randomized crossover comparative study of “Mochida” and filgrastim. The results of this study showed no significant difference in the mean duration of neutropenia, incidence of febrile neutropenia (FN), incidence of absolute neutrophil count (ANC) less than 1000, and mean duration of ANC nadir between the two drugs. Although there were only 16 patients in this study, “Mochida” showed no significant difference with filgrastim for efficacy, and it was suggested that “Mochida” is an effective drug for avoiding FN expression after chemotherapy. In addition, “Mochida” costs 54%-69% of the price for filgrastim. Thus, “Mochida” may contribute to maintaining quality of life.

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© 2015 日本医療薬学会
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