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诺华生物仿制药Rituxan在美国推迟使用

2018-05-06 MedSci MedSci原创

诺华生物仿制药Rituxan美国推迟
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诺华的Sandoz部门今天宣布，美国FDA已经就其生物仿制药Rituxan的生物制剂许可申请（BLA）发布了完整的回复函，意味着该药的批准在该国已经推迟。这封信对Rituxan的原研药营销商罗氏来说是个好消息，罗氏药物在美国的销售额约为40亿美元。该公司在一份声明中表示："Sandoz认为监管提交中包含了有力证据，目前正在评估这封信的内容。" "虽然失望，Sandoz仍然致力于与FDA进一步讨论，


诺华的Sandoz部门今天宣布，美国FDA已经就其生物仿制药Rituxan的生物制剂许可申请（BLA）发布了完整的回复函，意味着该药的批准在该国已经推迟。

这封信对Rituxan的原研药营销商罗氏来说是个好消息，罗氏药物在美国的销售额约为40亿美元。

该公司在一份声明中表示："Sandoz认为监管提交中包含了有力证据，目前正在评估这封信的内容。" "虽然失望，Sandoz仍然致力于与FDA进一步讨论，以便尽快将这种重要药物带给美国患者。"
另一种由Celltrion和Teva生产的生物仿制药Rituxan上个月被FDA拒绝。

Celltrion和Novartis生产的生物仿制药Rituximab已经在欧洲上市，2018年第一季度Rituxan在该地区的销售额下降了44％。


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    2018-05-23 小狸

    学习了

    0

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    2018-05-08 drwjr

    #仿制药#

    0

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    2018-05-08 nian.wang1982

    #诺华#

    0

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    2018-05-08 grace5701

    #生物仿制药#

    0

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    2018-05-07 1209e435m98(暂无昵称)

    学习了.谢谢分享

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=317870, encodeId=696831e87019, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bc832030729, createdName=小狸, createdTime=Wed May 23 15:28:32 CST 2018, time=2018-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261406, encodeId=e7df126140648, 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=20, 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=Tue May 08 00:10:00 CST 2018, time=2018-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282722, encodeId=5ba41282e2264, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Tue May 08 00:10:00 CST 2018, time=2018-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412912, encodeId=86e5141291260, 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=22, 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=Tue May 08 00:10:00 CST 2018, time=2018-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=312713, encodeId=9f6b312e135e, content=学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon May 07 06:08:31 CST 2018, time=2018-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=312534, encodeId=901531253447, content=学习了.谢谢分享., beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Sun May 06 11:20:46 CST 2018, time=2018-05-06, status=1, ipAttribution=)]
    2018-05-06 惠映实验室

    学习了.谢谢分享.

    0