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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

  2. [GetPortalCommentsPageByObjectIdResponse(id=1261394, encodeId=bec712613941b, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Sun Apr 08 12:48:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412909, encodeId=59c7141290991, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Sun Apr 08 12:48:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548180, encodeId=e6a015481800a, content=<a href='/topic/show?id=48b98e537f' target=_blank style='color:#2F92EE;'>#Herceptin#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8753, encryptionId=48b98e537f, topicName=Herceptin)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5ecc14021123, createdName=minhuang75_72521588, createdTime=Sun Apr 08 12:48:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=303400, encodeId=25d3303400f2, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Sat Apr 07 00:10:08 CST 2018, time=2018-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=303383, encodeId=f6ee30338333, content=不错的文章值得拥有, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Fri Apr 06 22:45:42 CST 2018, time=2018-04-06, status=1, ipAttribution=)]
    2018-04-08 grace5701

    #生物仿制药#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1261394, encodeId=bec712613941b, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Sun Apr 08 12:48:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412909, encodeId=59c7141290991, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Sun Apr 08 12:48:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548180, encodeId=e6a015481800a, content=<a href='/topic/show?id=48b98e537f' target=_blank style='color:#2F92EE;'>#Herceptin#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8753, encryptionId=48b98e537f, topicName=Herceptin)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5ecc14021123, createdName=minhuang75_72521588, createdTime=Sun Apr 08 12:48:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=303400, encodeId=25d3303400f2, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Sat Apr 07 00:10:08 CST 2018, time=2018-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=303383, encodeId=f6ee30338333, content=不错的文章值得拥有, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Fri Apr 06 22:45:42 CST 2018, time=2018-04-06, status=1, ipAttribution=)]
    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

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