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CHMP对Mylan和Fujifilm的阿达木单抗生物类似物Hulio持积极态度

2018-07-29 MedSci MedSci原创

FujifilmMylan阿达木单抗Hulio
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Mylan和Fujifilm生物制药公司近日宣布，欧洲药品管理局的人用药品委员会（CHMP）对Hulio的营销授权申请持积极的意见，Hulio为Humira（adalimumab，阿达木单抗）的生物类似物，适用于阿达木单抗的所有适应症。

类风湿关节炎 (RA) 是一种以对称性、多关节、小关节为主的慢性自身免疫性疾病，素有“不死癌症”之称，患病者的免疫系统会破坏健康关节，引发关节疼痛、肿胀、僵硬，产生疲劳和无力的症状，晚期可强直和畸形、功能严重受损，并最终导致关节功能丧失。阿达木单抗已经成为RA治疗的先进生物靶向性药物。

Mylan和Fujifilm生物制药公司近日宣布，欧洲药品管理局的人用药品委员会（CHMP）对Hulio的营销授权申请持积极的意见，Hulio为Humira（adalimumab，阿达木单抗）的生物类似物，适用于阿达木单抗的所有适应症。

Mylan首席执行官Heather Bresch评论说：“我们迫切需要为患有类风湿性关节炎、斑块状银屑病和克罗恩病等慢性炎症的患者提供更实惠的治疗选择。CHMP的决定基于Hulio与adalimumab生物相似结果，代表了向患者提供这种治疗的积极步骤”。Fujifilm总裁兼首席执行官Yoshifumi Torii博士说：“我们将继续致力于提供高质量的生物仿制药，并强烈希望Hulio为整个欧洲国家的患者提供巨大的价值”。Mylan总裁Rajiv Malik补充道：“Mylan非常自豪能成为欧洲第一波阿达木单抗生物仿制药的制造商之一。我们将继续在全球市场寻找机会，为患者增加治疗选择，并尽量减少医疗成本负担”。


原始出处：

http://www.firstwordpharma.com/node/1581494?tsid=4#axzz5MVjkDWbV

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    2018-10-12 haouestc

    #Mylan#

    0

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    2019-03-03 124985dbm17(暂无昵称)

    #阿达木单抗生物类似物#

    0

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    2018-11-27 JR19860219

    #JIF#

    0

  4. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:42 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-31 医生2394

    #CHMP#

    0

  5. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:42 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-31 waiwai3036

    #Hulio#

    0

  6. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:42 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-31 1179102698_36768932

    #阿达木#

    0

  7. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:42 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-30 kafei

    了解一下谢谢

    0

  8. 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encodeId=556c33501e1b, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, 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=Mon Jul 30 01:19:18 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334994, encodeId=0eb933499417, content=学习了学习了我，谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1bb241978, createdName=phoebeyan520, createdTime=Sun Jul 29 23:20:03 CST 2018, time=2018-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334985, encodeId=7168334985cc, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:42 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-30 飛歌

    学习了很有用不错

    0

  9. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:42 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-29 phoebeyan520

    学习了学习了我，谢谢

    0

  10. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:42 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-29 清风拂面

    谢谢分享学习

    0

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