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辉瑞赫赛汀生物仿制药达乳腺癌III期临床试验主要终点

2016-12-26 佚名 生物谷

近年来,许多重磅炸弹药物的专利期纷纷到期,原研药极有可能被生物仿制药抢占市场份额,面临“专利断崖”的危机。近日辉瑞公布了罗氏赫赛汀的生物仿制药在HER2阳性转移性乳腺癌中的临床试验数据。数据表示在25周的治疗之后,PF-05280014客观缓解率与原研药等同,具有生物等效性,达到了临床试验的主要终点。 B3271002是一项比较、随机、双盲对照试验,它评估了PF-05280014联合紫杉


近年来,许多重磅炸弹药物的专利期纷纷到期,原研药极有可能被生物仿制药抢占市场份额,面临“专利断崖”的危机。近日辉瑞公布了罗氏赫赛汀的生物仿制药在HER2阳性转移性乳腺癌中的临床试验数据。数据表示在25周的治疗之后,PF-05280014客观缓解率与原研药等同,具有生物等效性,达到了临床试验的主要终点。

B3271002是一项比较、随机、双盲对照试验,它评估了PF-05280014联合紫杉醇作为HER2阳性转移性乳腺癌的一线治疗方案的有效性、安全性、药物动力学和免疫原性,对照组为赫赛汀联合多烯紫杉醇。另一项在早期乳腺癌患者中开展的独立临床试验B3271004也表明,PF-05280014治疗早期乳腺癌也达到了临床试验的主要终点,具有生物等效性。

辉瑞Essential Health研发部门负责人Sumant Ramachandra表示,越来越多的生物仿制药上市后收获了较好的反响,这加深了医生和患者对生物仿制药的理解,树立了他们的信心,有助于市场认识到仿制药的价值和重要性。辉瑞对于赫赛汀仿制药PF-05280014的临床试验数据非常满意,将会向监管部门提交数据和上市申请。

PF-05280014作为辉瑞版本的赫赛汀生物仿制药,旨在应用于所有赫赛汀获批的适应症,目前还处于临床试验阶段,未被任何一个国家批准上市。赫赛汀作为制药巨头罗氏的重磅抗癌药,目前已经在美国、欧洲和其它市场获批用于HER2阳性的乳腺癌和胃癌

目前赫赛汀遭遇的仿制药竞争主要来自于迈兰和安进/艾尔建。迈兰已经向FDA和EMA提交了自身版本赫赛汀仿制药的上市申请,安进/艾尔建也已经发表了临床试验数据结果,表明ABP 980与赫赛汀具有生物等效性。通常某款重磅药物的首个上市的仿制药将会占领主要的仿制药市场,因此迈兰和安进/艾尔建之间亦存在激烈的竞争。

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  4. 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time=2016-12-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588001, encodeId=b4d715880019e, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Wed Dec 28 03:44:00 CST 2016, time=2016-12-28, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1996934, encodeId=eeae1996934c9, content=<a href='/topic/show?id=b706232e831' target=_blank style='color:#2F92EE;'>#主要终点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23278, encryptionId=b706232e831, topicName=主要终点)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7387164, createdName=zhangj7108, createdTime=Thu Aug 03 06:44:00 CST 2017, time=2017-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931424, encodeId=b3ec193142474, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, 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time=2016-12-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588001, encodeId=b4d715880019e, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Wed Dec 28 03:44:00 CST 2016, time=2016-12-28, status=1, ipAttribution=)]
    2017-10-09 juliusluan78
  6. 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  7. 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time=2016-12-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588001, encodeId=b4d715880019e, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Wed Dec 28 03:44:00 CST 2016, time=2016-12-28, status=1, ipAttribution=)]
    2016-12-28 wrj0122
  8. 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  9. [GetPortalCommentsPageByObjectIdResponse(id=1996934, encodeId=eeae1996934c9, content=<a href='/topic/show?id=b706232e831' target=_blank style='color:#2F92EE;'>#主要终点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23278, encryptionId=b706232e831, topicName=主要终点)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7387164, createdName=zhangj7108, createdTime=Thu Aug 03 06:44:00 CST 2017, time=2017-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931424, encodeId=b3ec193142474, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, 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