FDA提前三个月批准施贵宝PD-1抑制剂Nivolumab(Opdivo),与Keytruda同价

2014-12-24 佚名 美中药源

今天FDA批准了施贵宝PD-1抑制剂Nivolumab(商品名Opdivo)作为末线药物治疗黑色素瘤。这比原计划的PDUFA时间(2015年3月) 提前三个多月,显示FDA对真正创新药物的友好态度。这是2011年以来批准的第七个黑色素瘤药物,而2011年以前转移黑色素瘤几乎没有治疗办法。这也是继默克Keytruda之后第二个在美国上市的PD-1抑制剂。免疫哨卡抑制剂的竞争全面展开。 【药源解析】

今天FDA批准了施贵宝PD-1抑制剂Nivolumab(商品名Opdivo)作为末线药物治疗黑色素瘤。这比原计划的PDUFA时间(2015年3月) 提前三个多月,显示FDA对真正创新药物的友好态度。这是2011年以来批准的第七个黑色素瘤药物,而2011年以前转移黑色素瘤几乎没有治疗办法。这也是继默克Keytruda之后第二个在美国上市的PD-1抑制剂。免疫哨卡抑制剂的竞争全面展开。

【药源解析】: Opdivo已经在日本上市,没什么人怀疑FDA会批准这个药物,但提前这么久多少有点出人意料,比Keytruda提前的还多。这显示FDA对真正创新药物的态度。如果你的产品真正能治病救人,FDA基本不会成为限速步骤。

黑色素瘤是PD-1抑制剂诸多适应症之一,可能算是比较小的适应症,但因每个月1.25万美元的药价据说仅这个适应症的市场每年就可达50亿美元。PD-1抑制剂已经在6、7种癌症显示疗效,但最大的当属肺癌。Opdivo和Keytruda都在肺癌显示非常显著的疗效,Opdivo已经在三期临床显示生存优势,明年可望批准上市。今后5年这两个产品都可以成为超大产品。

作为me-too药物Opdivo和Keytruda的价格相同,主要是因为在肺癌Opdivo处于领先位置,否则可能需要通过打折(rebate)来争取市场。今天美国最大的处方药管理公司Express Scripts(职责之一是替保险公司谈判药价)宣布将丙肝药物Harvoni从支付名单上剔除而用Viekira Pak替代,因为Viekira Pak打折后比Harvoni便宜很多(具体多少并未公布),结果令吉利德科学股票暴跌15%,蒸发200多亿美元市值。历史上制药公司极少通过价格竞争市场,但最近几年这个其它行业的基本竞争手段开始进入新药领域,最突出的是葛兰素的COPD药物Breo和Anoro。这令很多处于竞争劣势的公司十分紧张。PD-1、PCSK9等领域都是竞争十分激烈、投入十分巨大的领域,如果第二、第三上市的药物不得不通过降价获得市场份额,这将对新药的商业模式产生巨大影响。今天Street.com的分析家甚至说只有像Bluebird Bio这样开发me-only产品的模式才能生存。

现在的所谓me-too药物和很多人想的不同,并非别人趟好路你再开始。有点市场价值的me-too和奥运会田径比赛类似,冠军和亚军同时起跑,水平十分接近,只是由于细微差别造成上市先后的区别,即使这样后上市的me-too药物都面临支付部门的要挟。如果你等冠军撞线才上跑道,观众早就回家了。这样等别人把路线跑完才开始的me-too虽然技术上安全,但市场价值几乎没有,已经不能作为一种研发模式而生存。

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    2015-12-27 忠诚向上

    很值得学习

    0

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    2015-09-27 tamgche
  3. [GetPortalCommentsPageByObjectIdResponse(id=49564, encodeId=fcff495646e, content=很值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Sun Dec 27 19:56:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007840, encodeId=38d1200e84097, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sun Sep 27 18:25:00 CST 2015, time=2015-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911675, encodeId=0f0719116e598, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Fri Feb 06 23:25:00 CST 2015, time=2015-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851214, encodeId=d2cb1851214cc, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Mon Jan 19 15:25:00 CST 2015, time=2015-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1685273, encodeId=e11516852e315, content=<a href='/topic/show?id=03135881224' target=_blank style='color:#2F92EE;'>#施贵宝#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58812, encryptionId=03135881224, topicName=施贵宝)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=394828104279, createdName=jktdtl, createdTime=Mon Sep 07 10:25:00 CST 2015, time=2015-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1278920, encodeId=daaa12e89201a, content=<a href='/topic/show?id=70e6139138a' target=_blank style='color:#2F92EE;'>#PD-1抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13913, encryptionId=70e6139138a, topicName=PD-1抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=84fb152, createdName=xiongliangxl, createdTime=Fri Dec 26 00:25:00 CST 2014, time=2014-12-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1303035, encodeId=320e1303035cc, content=<a href='/topic/show?id=4264134043c' target=_blank style='color:#2F92EE;'>#Opdivo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13404, encryptionId=4264134043c, topicName=Opdivo)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fda6311, createdName=119337457, createdTime=Fri Dec 26 00:25:00 CST 2014, time=2014-12-26, status=1, ipAttribution=)]
    2015-02-06 snf701207
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    2015-01-19 jklm09
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    2015-09-07 jktdtl
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    2014-12-26 119337457

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