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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=66, 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=66, 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=66, 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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encodeId=556c33501e1b, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, 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=66, 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=66, 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. [GetPortalCommentsPageByObjectIdResponse(id=2030229, encodeId=3d8520302293b, content=<a href='/topic/show?id=7ee11242187' target=_blank style='color:#2F92EE;'>#Mylan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12421, encryptionId=7ee11242187, topicName=Mylan)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Fri Oct 12 21:33:00 CST 2018, time=2018-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737940, encodeId=139f1e3794041, content=<a href='/topic/show?id=52f99e94828' target=_blank style='color:#2F92EE;'>#阿达木单抗生物类似物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97948, encryptionId=52f99e94828, topicName=阿达木单抗生物类似物)], attachment=null, authenticateStatus=null, 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topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Tue Jul 31 12:33:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590874, encodeId=710f15908e466, content=<a href='/topic/show?id=96c4919568' target=_blank style='color:#2F92EE;'>#Hulio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9195, encryptionId=96c4919568, topicName=Hulio)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=00ae17877069, createdName=waiwai3036, createdTime=Tue Jul 31 12:33:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1615623, encodeId=4f1f161562301, content=<a href='/topic/show?id=3eb39e945b2' target=_blank style='color:#2F92EE;'>#阿达木#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97945, encryptionId=3eb39e945b2, topicName=阿达木)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3dba19658752, createdName=1179102698_36768932, createdTime=Tue Jul 31 12:33:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335076, encodeId=65d23350e681, content=了解一下谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLbTp9nZtjwVrSZNxAXbAicnKQWnic2eBdJUQYhxO36XdkstSicr7FVF8p5ReH4omtmsbnLdvZLiaJJ1A/132, createdBy=8bff2327056, createdName=kafei, createdTime=Mon Jul 30 08:47:16 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335017, encodeId=556c33501e1b, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, 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=66, 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=66, 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. [GetPortalCommentsPageByObjectIdResponse(id=2030229, encodeId=3d8520302293b, content=<a href='/topic/show?id=7ee11242187' target=_blank style='color:#2F92EE;'>#Mylan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12421, encryptionId=7ee11242187, topicName=Mylan)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Fri Oct 12 21:33:00 CST 2018, time=2018-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737940, encodeId=139f1e3794041, content=<a href='/topic/show?id=52f99e94828' target=_blank style='color:#2F92EE;'>#阿达木单抗生物类似物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97948, encryptionId=52f99e94828, topicName=阿达木单抗生物类似物)], attachment=null, authenticateStatus=null, 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beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97945, encryptionId=3eb39e945b2, topicName=阿达木)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3dba19658752, createdName=1179102698_36768932, createdTime=Tue Jul 31 12:33:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335076, encodeId=65d23350e681, content=了解一下谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLbTp9nZtjwVrSZNxAXbAicnKQWnic2eBdJUQYhxO36XdkstSicr7FVF8p5ReH4omtmsbnLdvZLiaJJ1A/132, createdBy=8bff2327056, createdName=kafei, createdTime=Mon Jul 30 08:47:16 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335017, encodeId=556c33501e1b, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, 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=66, 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=66, 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. [GetPortalCommentsPageByObjectIdResponse(id=2030229, encodeId=3d8520302293b, content=<a href='/topic/show?id=7ee11242187' target=_blank style='color:#2F92EE;'>#Mylan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12421, encryptionId=7ee11242187, topicName=Mylan)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Fri Oct 12 21:33:00 CST 2018, time=2018-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737940, encodeId=139f1e3794041, content=<a href='/topic/show?id=52f99e94828' target=_blank style='color:#2F92EE;'>#阿达木单抗生物类似物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97948, encryptionId=52f99e94828, topicName=阿达木单抗生物类似物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5dd734305234, createdName=124985dbm17(暂无昵称), createdTime=Sun Mar 03 01:33:00 CST 2019, time=2019-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088652, encodeId=5b9d20886521a, content=<a href='/topic/show?id=45ee103010a' target=_blank style='color:#2F92EE;'>#JIF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10301, encryptionId=45ee103010a, topicName=JIF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=20b5274, createdName=JR19860219, createdTime=Tue Nov 27 14:33:00 CST 2018, time=2018-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302657, encodeId=e0d9130265e24, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Tue Jul 31 12:33:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590874, encodeId=710f15908e466, content=<a href='/topic/show?id=96c4919568' target=_blank style='color:#2F92EE;'>#Hulio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9195, encryptionId=96c4919568, topicName=Hulio)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=00ae17877069, createdName=waiwai3036, createdTime=Tue Jul 31 12:33:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1615623, encodeId=4f1f161562301, content=<a href='/topic/show?id=3eb39e945b2' target=_blank style='color:#2F92EE;'>#阿达木#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97945, encryptionId=3eb39e945b2, topicName=阿达木)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3dba19658752, createdName=1179102698_36768932, createdTime=Tue Jul 31 12:33:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335076, encodeId=65d23350e681, content=了解一下谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLbTp9nZtjwVrSZNxAXbAicnKQWnic2eBdJUQYhxO36XdkstSicr7FVF8p5ReH4omtmsbnLdvZLiaJJ1A/132, createdBy=8bff2327056, createdName=kafei, createdTime=Mon Jul 30 08:47:16 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335017, encodeId=556c33501e1b, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, 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=66, 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=66, 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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