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美国拒绝罗氏Rituxan和Herceptin生物仿制药的申请

2018-04-06 MedSci MedSci原创

Rituxan和Herceptin的生物仿制药
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美国食品和药物管理局拒绝了Celltrion提交的罗氏制药的Rituxan和Herceptin的生物仿制药的申请。据媒体报道，该公司收到Herzuma（曲妥珠单抗； CT-P6）和Truxima（利妥昔单抗； CT-P10）的完整回复信。Celltrion告诉BioCentury，这些问题直接与今年1月监管机构发布的一份警告有关，该警告是针对GMP在其制造工厂的违规行为。Celltrion还向该刊


美国食品和药物管理局拒绝了Celltrion提交的罗氏制药的Rituxan和Herceptin的生物仿制药的申请。

据媒体报道，该公司收到Herzuma（曲妥珠单抗； CT-P6）和Truxima（利妥昔单抗； CT-P10）的完整回复信。

Celltrion告诉BioCentury，这些问题直接与今年1月监管机构发布的一份警告有关，该警告是针对GMP在其制造工厂的违规行为。

Celltrion还向该刊物表示，它打算"相对较快"地重新提交申请，并预计在六个月后获得批准。

欧洲药品管理局2月份批准Herzuma用于早期乳腺癌，转移性乳腺癌或肿瘤有HER2过表达或HER2基因扩增的转移性胃癌患者，以及去年早些时候Truxima用于治疗某些癌症和炎性疾病。


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    2018-04-08 drwjr

    #仿制药#

    0

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    2018-04-08 grace5701

    #生物仿制药#

    0

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    2018-04-08 minhuang75_72521588

    #Herceptin#

    0

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    2018-04-07 飛歌

    学习了很有用不错

    0

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    2018-04-06 1e1b8538m79(暂无匿称)

    不错的文章值得拥有

    0