秒速赛车控制器

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WHO通過首款生物類似藥預認證——曲妥珠單抗
發布時間: 2019-12-24     來源: 醫藥魔方

YUANCHUANG: SIBIAN

秒速赛车控制器2019NIAN12YUE18RI,SHIJIEWEISHENGZUZHIDUISHOUKUANQUTUOZHUDANKANGSHENGWULEISIYAOTONGGUOLEYURENZHENG,ZHEYIJUCUOYIWEIZHUZHEKUANANGGUIDEKANGAIJIUMINGYAOZAIQUANQIUFANWEINEIGENGWEIKEFUDAN,HUIYIQUANQIUNVXINGHUANZHE。ZHESHITONGGUOSHIWEIZUZHIYURENZHENGDESHOUKUANSHENGWULEISIYAO。

秒速赛车控制器RUXIANAISHINVXINGQUNTIBIJIAOCHANGJIANDEAIZHENG。2018NIAN,QUANQIUYUEYOU210WANNVXINGBEIQUEZHENWEIHUANYOURUXIANAI,QIZHONGYOU63WANRENZUIZHONGSIYURUXIANAI,HENDUOSHIYINWEIGUOWANZHENDUANYIJIQUEFAKEFUDANDEZHILIAO。ZHONGSUOZHOUZHIDEQUTUOZHUDANKANG(YUANYANYAOSHANGPINMING:Herceptin)SHIAIZHENGZHILIAOLINGYUDEDIYIGEDAFENZIBAXIANGXINGYAOWU,YOULUOSHIYANFA,ZHUYAOYONGYUZHILIAOHER2YANGXINGXINGRUXIANAI,SHIYIZHONGZHONGZUDNAYANSHENGDERENYUANHUADANKELONGKANGTI,BAXIANGZUOYONGYUHER2(RENBIAOPISHENGCHANGYINZISHOUTI2)DEXIBAOWAIBUWEI。1998NIAN,HerceptinHUOMEIGUOFDAPIZHUN,LVXIANZAIMEIGUOSHANGSHI。2000NIANZAIOUMENGHUOPISHANGSHI,2001NIANZAIRIBENSHANGSHI。2002NIANCFDAPIZHUNHerceptinZAIZHONGGUOSHANGSHI,ZHUYAOZHILIAORUXIANAI。2015NIAN,QUTUOZHUDANKANGBEILIERUSHIWEIZUZHI《JIBENYAOWUSHIFANMULU》。

秒速赛车控制器ZUOWEILUOSHIDEWANGPAIYUANYANYAO,HerceptinDUONIANLAIYIZHIMINGLIEQUANQIUYAOPINXIAOSHOUEPAIXINGBANGQIANSHIWEI,DANSHIQUANQIUPINGJUNJIAGEYUE2WANMEIYUAN,DADUOSHUGUOJIADENVXINGHUANZHEYIJIGUOJIAYILIAOXITONGDOUWULICHENGDAN。QUTUOZHUDANKANGLEISIYAODEJIAGEDAZHIBIYUANYANYAOBIANYI65%。JIANYUQIBEILIERUSHIWEIZUZHIDE《JIBENYAOWUSHIFANMULU》,BINGQIEHUANYOUGENGDUOTONGKUANLEISIYAOZAIYURENZHENGGUANXIANZHONG,JIAGEYOUWANGJINYIBUXIAJIANG。

SHIWEIZUZHIZONGGANSHITANDESAIBOSHISHUO:“SHIWEIZUZHIDUIQUTUOZHUDANKANGDEYURENZHENGDUIYUGEDINVXINGERYANSHIHAOXIAOXI。ZAIXUDUOWENHUAZHONG,NVXINGZAIHUODEBAOJIANFUWUFANGMIANZAOSHOUXINGBIECHAYIDEKUNRAO。ZAIPINQIONGGUOJIA,ZENGJIALEXUDUORENWUFAHUODEZHILIAODEFUDAN,ERQIEYAOPINJIAGEGAOANG。YOUXIAOQIEKEFUDANDERUXIANAIZHILIAOYINGDANGSHISUOYOUFUNVDEQUANLI,ERBUZHISHISHAOSHURENDETEQUAN。”

秒速赛车控制器CICIHUODEYURENZHENGDESHISANXINGBioepisDEQUTUOZHUDANKANGLEISIYAO,JIYUGAIKUANLEISIYAOZAIYOUXIAOXING、ANQUANXINGHEZHILIANGFANGMIANYUYUANYANCHANPINJUYOUKEBIXING。ZHEYIYURENZHENGYIWEIZHULIANHEGUOXITONGDEYAOPINCAIGOUJIGOUYIJIGEGUOGUONEIYAOPINCAIGOUFANGKEYICAIGOUZHEKUANLEISIYAO。GUOQUWUNIAN,YOUDUOKUANQUTUOZHUDANKANGLEISIYAOHUOPISHANGSHI,DANSHIDOUMEIYOUHUODESHIWEIZUZHIDEYURENZHENG。

SHIWEIZUZHIGUOJIAIZHENGYANJIUJIGOUYUJI,DAO2040NIAN,YIZHENDUANCHUDERUXIANAISHULIANGJIANGDADAO310WAN,QIZHONGZHONGDISHOURUGUOJIADEZENGFUZUIDA。ZHEYIYURENZHENGWEIHENDUOGUOJIA(YOUQISHIZHONGDISHOURUGUOJIA)CAIGOUYOUZHIDEQUTUOZHUDANKANGLEISIYAOTIGONGLEBAOZHENG。

世界衛生組織的預認證

SHIWEIZUZHIYAOWUYURENZHENGGUIHUAYOUZHUYUJIAKUAIHEZENGJIAHUOQUYOUZHILIANGBAOZHENG、KEFUDANBINGSHIHEZHONGDISHOURUGUOJIASHICHANGDEZHONGYAOYILIAOCHANPIN。GAIGUIHUATONGGUOPINGJIAZHIZAOSHANGKAIFADEYILIAOCHANPINLAIQUEBAOQIZHILIANG、ANQUANXINGHEGONGXIAO,JINERKUODAXIANYOUYOUZHIYAOWUDECHUBEI。DUIWEISHENGCHANPINJINXINGPINGJIAHEYURENZHENGHOU,ZHEXIECHANPINHUILIEZAIYURENZHENGQINGDANZHONG,GUOJIYAOPINCAIGOUJIGOU(RUQUANQIUJIJIN,QUANQIUYIMIAOMIANYILIANMENGHELIANHEGUOERTONGJIJINHUIDENG)YIJIYUELAIYUEDUODEGEGUOYAOPINCAIGOUJIGOUKEYIJIAODIDEJIAGEPILIANGCAIGOUYAOWU、YIMIAO、ZHENDUANGONGJUHEQITAZHONGYAOCHANPIN。BUSHAODISHOURUGUOJIAHUOZHEYAOPINJIANGUANNENGLIBUZUDEGUOJIAYEHUIGENJUSHIWEIZUZHIYURENZHENGZHIDAOBENGUODEYAOPINCAIGOU。YINCI,SHIWEIZUZHIDEYURENZHENGDUIYUHUANZHE(YOUQISHENGHUOZAIWULIJINXINGYAOWUANQUANXINGHEYOUXIAOXINGJIANGUANDEGUOJIA)ERYANFEICHANGZHONGYAO。

LISHISHANG,YURENZHENGGUIHUAZHUYAOWEILIANHEGUOYAOPINCAIGOUJIGOUCAIGOUKANGAIZIBING、JIEHEBINGHENVEJIYAOWUDENGSHELI,ZHIHOUKUOZHANDAOYIXIESHENGZHIJIANKANGYAOWU、ZHENDUANQIXIEYIJIBEIHULVEJIBINGZHILIAO。2018NIAN7YUE,SHIWEIZUZHIQIDONGLESHIDIANGUIHUA,JIANGYURENZHENGDEFANWEIKUODADAOLIANGKUANSHENGWUYAO,FENBIESHIZHILIAORUXIANAIDEQUTUOZHUDANKANGHEZHILIAOFEIHUOQIJINLINBALIUDELITUOXIDANKANG,CUJINZHONGDISHOURUGUOJIAHUODEKEFUDANQIEZHILIANGYOUBAOZHANGDEAIZHENGZHILIAOFANGFA。SHIJIANZHONG,YUYINGDUIHEZHILIAOAIZIBING、JIEHEBINGHENVEJIDENGCHUANRANXINGJIBINGDEYAOPINXIANGBI,GUOJIYAOPINCAIGOUJIGOUDUIKANGAIYAODECAIGOULIANGBUHUIHENDA,DANSHI,JIANGKANGAIYAOLIERUYURENZHENGFANWEIBIAOMINGKANGAIYAOYESHIGEGUOTUIJINQUANMINYIBAO(Universal Health Coverage)DEYIBUFEN。

BUGUO,YEYOUGUANCHARENSHIZHICHU,JINJINJIANGDIHerceptinZHEXIEKANGAIYAODEJIAGEBINGBUZUYISHIZHONGDISHOURUGUOJIADENVXINGHUANZHEKEYIHUODEKANGAIZHILIAO。SHIYONGZHEXIEKANGAIYAODESHIYONGSHOUXIANYAOQIUJUBEIGONGNENGLIANGHAODEYILIAOWEISHENGTIXI,KEYIZAOQIZHENDUANCHUAIZHENGZHONGLIU,SUIHOUJINXINGSHIDANGDESHOUSHUJIFANGHUALIAO,ZHEXIESHIZUIJIASHIYONGSHENGWUYAOWUZHILIAODEXIANJUETIAOJIAN。

CHULEDUIYISHANGLIANGKUANKANGAISHENGWUYAOKAIZHANYURENZHENGZHIWAI,SHIWEIZUZHIHUANYUJINNIANSHIJIETANGNIAOBINGRI(11YUE14RI)ZHIQIANXUANBUQIDONGYIXIANGXINDESHIDIANGUIHUA,DUIRENYIDAOSUJINXINGYURENZHENG,YIJIAQIANGZHONGDISHOURUGUOJIADUITANGNIAOBINGDEZHILIAO,YINGDUISUOYOUQUYURIYISHANGSHENGDETANGNIAOBINGFUDAN。KEYIYUJIAN,WEILAIJIANGYOUYUELAIYUEDUODEFEICHUANRANXINGJIBINGZHILIAOYAOWUHUINARUYURENZHENGTIXI,CUJINGEGUO(YOUQIZHONGDISHOURUGUOJIA)HUODEKEFUDANBINGQIEZHILIANGYOUBAOZHANGDEZHILIAO。

Herceptin類似藥全球競爭格局

2015NIAN,HerceptinZAIMEIGUODEHEXINZHUANLIDAOQI,FANGZHIYAOQIYEFENFENKAISHIXINGDONG,HerceptinSHENGWULEISIYAODEKAIFACHENGWEIQUANQIUZHIYAOJIEDEYIGEREDIAN。

FANGZHIYAOJUTOUMylanLVXIANDUIHEXINZHUANLIYIWAISHEJIDAOKANGTIDEZHIBEIFANGFA、ZHIJIHEZHILIAOFANGFADENGZHUANLIFAQITIAOZHAN(HOULUOSHIYUMylanDACHENGHEJIE)BINGYU2016NIAN11YUETICHULESHENGWULEISIYAODESHANGSHISHENQING,YUQIANGZHANMEIGUOSHICHANGDEHerceptinSHOUFANGYAOXIANJI。CIWAI,HUIRUI/Hospira,Celltrion/TIWAYEDOUDUIHerceptinDEZHONGYAOZHUANLITICHUGUOTIAOZHAN,YIYUJINKUAISHANGSHIZHENGDUOLUOSHIHerceptinZAIMEIGUOSHICHANGDEFENE。

FDA批準的曲妥珠單抗生物類似藥

CHULEMEIGUOSHICHANGWAI,YINDUBAIKANG(Biocon)YUMylanHEZUOZAIQUANQIUFANWEINEIKAIFAHerceptinLEISIYAO,ZAOZAI2013NIAN11YUEHUOYINDUYAOPINJIANGUANJIGOUPIZHUN,2016NIAN9YUE,MylanYOUXIANGEMATIJIAOLEGAILEISIYAODESHANGSHISHENQING。HANGUOCelltrionGONGSIDELEISIYAOHerzumaYU2014NIANHUOHANGUOSHIPINYAOPINANQUANBU(MFDS)PIZHUN,GAIGONGSIYEYU2016NIANXIANGEMATIJIAOLESHANGSHISHENQING。

Herceptin類似藥在中國

2017NIAN11YUE,CDEFABU《ZHUSHEYONGQUTUOZHUDANKANGSHENGWULEISIYAOLINCHUANGYANJIUSHEJIJISHENPINGKAOLVYAODIAN》GONGKAIZHENGQIUYIJIAN,JIEHEGAIPINZHONGTEDIANXIHUAFANGZHICELVE,GULIGENGDUOZHONGGUOBENTUQIYEJIJIYANZHIHerceptinSHENGWULEISIYAO。MUQIANGUONEIQUTUOZHUDANKANGSHENGWULEISIYAODEYANFAJINDUZUIKUAIDESHIFUHONGHANLIN,YIJINGTIJIAOLESHANGSHISHENQING,LINGWAIYOUHAIZHENGYAOYE、HUALANSHENGWU、ANKESHENGWU、JIAHESHENGWUDENGCHUYUIIIQILINCHUANGJIEDUAN。

GUONEIDANGQIANSHANGWUHerceptinLEISIYAOPIZHUNSHANGSHI,WEIBAOZHUSHICHANGFENE,LUOSHIYIYUNYONGLEJIANGJIACELVE。2017NIAN7YUE,HerceptinCONGMEIZHIDE24500YUANJIANGZHI7600YUAN,YIJIN70%DEJIANGFUCHENGGONGRUWEILEGUOJIAYIBAOMULU。JINNIANGANGLUOMUDEGUOJIAYIBAOMULU,LUOSHIRENGXUANZEJIANGJIAXUYUE。SUIZHUWEILAIQUTUOZHUDANKANGLEISIYAOZAIGUONEIHUOPISHANGSHI,GUONEISHICHANGKENENGYEJIANGMIANLINJILIEJINGZHENG。SHIWEIZUZHIWEITUIJINANGGUIKANGAIYAOZAIQUANQIU(YOUQISHIZHONGDISHOURUGUOJIA)DEKEJIXINGERQIDONGDESHENGWULEISIYAOYURENZHENGGUIHUAHUOXUYEWEIZHONGGUOBENTUQIYEZAISHENGWULEISIYAOSHICHANGZHANLVEFANGMIANTIGONGLEYIXIEQIFA。

CANKAOZILIAO:

http://www.who.int/news-room/detail/18-12-2019-who-prequalifies-first-biosimilar-medicine-to-increase-worldwide-access-to-life-saving-breast-cancer-treatment

http://extranet.who.int/prequal/news/who-kick-starts-pilot-prequalification-biotherapeutics-cancer-treatment

秒速赛车控制器http://www.who.int/zh/news-room/detail/13-11-2019-who-launches-first-ever-insulin-prequalification-programme-to-expand-access-to-life-saving-treatment-for-diabetes

TiPLabSHENGWUYIYAOZHUANLIYANJIU:Herceptin®Herceptin®