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              輝瑞阿瓦斯汀仿制藥 bevacizumab 獲歐盟批準
              2019-02-22 14:35:50 來源:丁香園 瀏覽:2774

              輝瑞近日宣布,歐盟委員會已批準公司旗下的阿瓦斯汀生物仿制藥 Zirabev(bevacizumab)。

              該批準決定允許 bevacizumab 用于治療結腸或直腸轉移癌、轉移性乳腺癌、不可切除的晚期、轉移性或復發性非小細胞肺癌(NSCLC)、晚期和/或轉移性腎細胞癌以及持續性復發性或轉移性子宮頸癌。

              該批準基于一個全面的證據包,提供了該藥物與羅氏阿瓦斯汀的生物相似性。此次 bevacizumab 的批準決定遵循 2018 年 12 月歐洲人用藥品委員會(CHMP)的積極建議。此外,輝瑞已向美國 FDA 提交監管批準。

              「輝瑞公司致力于為患有嚴重疾病的患者增加生物仿制藥的使用范圍,并幫助建立更可持續的醫療系統,」輝瑞公司腫瘤學發達市場區域總裁 Andreas Penk 說道。

              「我們很自豪 Zirabev 今天被批準為我們在歐洲的第二個腫瘤生物仿制藥。這一里程碑反映了我們對生物仿制藥的持續承諾,因為我們繼續將高質量的藥物推向市場,可能有助于為癌癥治療節省成本。」

              輝瑞的中后期產品管線擁有強大的生物仿制藥候選產品組合,Zirabev 是該公司第五個獲批在歐洲使用的生物仿制藥。

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