辉瑞的美罗华仿制药RUXIENCE的营销申请,获得欧盟人用药物委员会的积极评价

2020-02-02 不详 MedSci原创

辉瑞公司宣布,其美罗华(利妥昔单抗)的潜在的生物仿制药RUXIENCE的营销授权申请,获得欧洲药品管理局(EMA)的人用药品管理委员会(CHMP)的积极意见。

辉瑞公司宣布,其美罗华(利妥昔单抗)的潜在的生物仿制药RUXIENCE的营销授权申请,获得欧洲药品管理局(EMA)的人用药品管理委员会(CHMP)的积极意见。

RUXIENCE作为一种单克隆抗体(mAb),可用于治疗非霍奇金淋巴瘤(NHL)、慢性淋巴细胞白血病(CLL)、类风湿性关节炎(RA)、肉芽肿合并多血管炎(GPA)和显微多血管炎(MPA),以及寻常型天疱疮(PV)。CHMP的意见现在将由欧盟委员会进行审查,并有望在2020年上半年做出监管决定。

辉瑞全球产品开发肿瘤学首席开发官Chris Boshoff博士说:"类似RUXIENCE的生物仿制药可以在癌症治疗中发挥重要作用。我们致力于将诸如RUXIENCE之类的生物仿制药作为一种治疗选择推向市场,其安全性和功效与原始产品相似,且价格可能更低。如果获得批准,RUXIENCE将成为辉瑞在欧洲获得监管机构批准的第五种肿瘤生物仿制药。"

监管意见书具有全面的数据支持,数据证明了RUXIENCE与参考产品的生物相似性。包括REFLECTIONS B3281006临床比较研究的结果,该研究评估了RUXIENCE的功效、安全性、免疫原性、药代动力学和药效学,发现在CD20阳性,低肿瘤负荷的滤泡性淋巴瘤患者中,与参比产品相比,在安全性或功效上无临床意义的差异。

原始出处:


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    2020-10-19 howi
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    2020-02-04 drwjr
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    2020-02-04 huagfeg

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