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CHMP对Mylan和Biocon的曲妥珠单抗生物类似物Ogivri持积极意见

2018-10-21 MedSci MedSci原创

Mylan制药和Biocon制药近日宣布,欧洲药品管理局委员会人用药品(CHMP)发表了积极意见,建议批准Ogivri(罗氏曲妥珠单抗的生物类似物)。

Mylan制药和Biocon制药近日宣布,欧洲药品管理局委员会人用药品(CHMP)发表了积极意见,建议批准Ogivri(罗氏曲妥珠单抗的生物类似物)。CHMP的积极意见基于分析测试、临床前和临床研究中的相似性评估。这些结果表明,Ogivri和曲妥珠单抗在质量、有效性和安全性方面没有临床意义上的差异。此外,在转移性乳腺癌患者的III期临床研究(Heritage),Ogivri和曲妥珠单抗在安全性、有效性和免疫原性方面没有表现出临床意义上的差异,进一步加强了Ogivri与曲妥珠单抗具有高度相似性的结论。

Ogivri适用于治疗HER2阳性早期乳腺癌(EBC),转移性乳腺癌(MBC)和转移性癌(MGC)患者。在相关医疗保健专业人员的监督下,可以将其作为单一疗法或与依赖于相关诊断的其他药物组合处方。


原始出处:

http://www.firstwordpharma.com/node/1598582#axzz5UXJIsme7

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    2019-08-04 haouestc
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    2018-11-28 sunylz
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    2018-10-23 daviiliu
  6. [GetPortalCommentsPageByObjectIdResponse(id=1722193, encodeId=23411e2219307, content=<a href='/topic/show?id=bdc0602328a' target=_blank style='color:#2F92EE;'>#曲妥珠单抗生物类似物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60232, encryptionId=bdc0602328a, topicName=曲妥珠单抗生物类似物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ef533209150, createdName=villahu, createdTime=Mon Oct 29 22:32:00 CST 2018, time=2018-10-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648134, encodeId=8c8816481345f, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sun Apr 07 02:32:00 CST 2019, time=2019-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2030230, encodeId=609d203023074, content=<a href='/topic/show?id=7ee11242187' target=_blank style='color:#2F92EE;'>#Mylan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, 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=Sun Aug 04 03:32:00 CST 2019, time=2019-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1918347, encodeId=e6e4191834e61, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Wed Nov 28 07:32:00 CST 2018, time=2018-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1269554, encodeId=96c3126955464, content=<a href='/topic/show?id=ae2e132e6c7' target=_blank style='color:#2F92EE;'>#Ogivri#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=125, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13276, encryptionId=ae2e132e6c7, topicName=Ogivri)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b3f89, createdName=daviiliu, createdTime=Tue Oct 23 07:32:00 CST 2018, time=2018-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302661, encodeId=3e811302661cf, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, 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 Oct 23 07:32:00 CST 2018, time=2018-10-23, status=1, ipAttribution=)]
    2018-10-23 医生2394
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