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生物类似药 VS. 化学仿制药

发布日期:2021-05-27


shengwuleisiyaohehuaxuefangzhiyaosuirandouyouzhegongtongdemubiao—zhibingjiuren,bingqiedoushuyufangzhiyaoleibie,danshiliangzhexianzhubutong。xiangbiyuhuaxuefangzhiyao,shengwuleisiyaozhuyaoyou“lianggao”detedian:jijishumenjiangao、touzimenjiangao。yibanrenweishengwuleisiyaoyanfatongchangxuyao8-10nian,bihuaxueyaofangzhiyao3-5nianyaozhanghenduo。shijiezuidadefangzhiyaogongsizhiyi、zhumingkuaguoyaoqinuohuaqixiadeshandeshirenweiyizhongdianxingdehuaxuefangzhiyaodefangzhichengbenwei2-3baiwanmeiyuan,erduiyushengwuleisiyaoeryan,zheiyishuzizegaoda0.75-2.5yimeiyuan,liangzhexiangchayuebaibei。jinguanshangshuyanfasuoxudeshijianhejinqianchengbenzaibutongdebaodaohuiyousuobutong,danshimeiyouzhengyideshi:shengwuleisiyaobihuaxuefangzhiyaosuoxushijiangengzhang,touzichengbengenggao。shangshudebutong,shiyouyuliangleiyaodezhuduobutongzaochengde,benwenjiulitutantaoliangzhedebutongzhichu。


表1 原创化学药与生物药的差异


化学药 生物药
产品本身的差异 化学合成 通过细胞或生物体生物合成
低分子量 高分子量
理化性质确定 理化性质复杂
稳定 对热敏感
单一分子实体,高度化学纯 非均一混合物,理化性质易变,难以标准化
可以不同方式给药 通常注射给药
通过毛细血管快速进入循环系统 更大的分子,主要通过淋巴系统进入循环系统,易于发生蛋白水解
可分布于任何器官/组织 通常只分布于血浆和/或胞外体液
通常有特定的毒性 绝大多数为受体介导的毒性
通常无抗原活性 通常有抗原活性
生产过程的差异 通过化学分析方法可以完全表征 难以表征
易于纯化 纯化过程长且复杂
污染通常易于避免,容易检测并去除污染物 更易混有污染物,检测更难,去除通常不太可能
生产过程与环境的微小变化对产品质量没有影响 产品质量对于生产过程与环境的微小变化非常敏感


yaoxianglejieshengwuleisiyaohehuaxuefangzhiyaodechayi,shouxianxuyaonongqingchuyuanyanshengwuyaohehuaxueyaodechabie,biao1jiuxitongzongjieleliangzhedechabie。biao2zezongjieleshengwuleisiyaohehuaxuefangzhiyaodezhuyaoqubie。


表2 生物类似药、化学仿制药与原研生物药之比较


过程 原研生物药 生物类似药 化学仿制药
生产制造过程 通过细胞或生物体生物合成 通过细胞或生物体生物合成 化学合成
对生产过程的变化敏感:昂贵的特定生产设施 对生产过程的变化敏感:昂贵的特定生产设施 对生产过程的变化不大敏感
很难重复性生产 很难重复性生产 易于重复性生产
临床实验过程 包括I-III临床实验 包括I-III临床实验 通常只需I期临床实验
上市后仍需进行药品安全监测(IV临床) 上市后仍需进行药品安全监测(IV临床) 审批时间更短
监管过程 需要证明“可比性” 需要证明“相似性” 在欧美,注册过程简化
目前不要求自动替代 通常不允许自动替代 允许自动替代


xiaofenzihuaxueyaotongchangshihuaxuehechengde,erdafenzishengwuyaozetongchangshishengwuhechengde。liangzhezaiyuantoudebutongjiuzhijiedaozhiliangzhezaijiegou、chengfen、shengchanfangfaheshebei、zhishichanquan、peifang、baocunfangfa、jiliang、jianguanfangshiyijixiaoshoufangshijunyoubutong。hehechengdexiaofenzihuaxueyaoxiangbi,shengwuyaozaifenzidaxiaoshangyaodayibaizhishangqianbei。birukangtiyaofenzilianggaoda15wandaoerdun,erhuaxueyaotongchangbudao1000daoerdun。youdebaodaojiangxiaofenzihuaxueyaodedaxiaobizuoyiliangzixingche,ershengwuyaodegetouzexiangdangyuyijiafeiji,qishiliangzhedequbiebujinjinshifenzidaxiaodechabie,gengzhongyaodeshishengwuyaodefenzijiegouyaoyuanbihuaxueyaofuza,birudanbaileiyaoyouyijijiegou(anjisuanxulie)heerjijiegou(ruαluoxuan、bzhediedeng)yijigengfuzadesanjijiegou。youxieshengwuyao,danbaifenzijiansanjijiegoudewendingjiehehaihuixingchengsijijiegou。gengweifuzadeshi,zaishengwuhechenghouzheixieshengwuyaodejiegoutongchanghuiyoufanyihouxiushi(jiptm),baokuotangjihua、linsuanhuadeng,erzheixiexiushi,butongpicideshengwuyaoyehuibujinxiangtong。erzheixiebianhuaduiyushengwuyaodeshengwuhuoxingkenengshihenguanjiande。jinguanshengwuyaohehuaxueyaodebutongdianhenduo,danshibizherenweizuihexinhezuizhongyaodequbieyouliangdian:duiyushengwuyaoeryan, bixutongshizhishaojubeilianggetiaojian: shengwutihechenghedafenzi。youxiexiaofenzihuaxueyaoyekeyicaiyongshengwuhechengfangfa;erxianzaideduotaihechengjishukeyihuaxuehechenggaodachaoguo100geanjisuan,fenziliangkeyishangwandaoerdun,danshijishishizheimedadeduotai(huozheshuoshixiaodanbai)yesuanbushangshengwuyao。


youyushengwuyaogengdadefenzilianghefuzadejiegou,shengwuyaodebiaozhengmianlinhendadetiaozhan。jinguansuizhexiandaikejidejinbu,fenxibiaozhengshengwuyaodejishushouduanyuelaiyuexianjin,danshiyouyushangshudetedian,jishiquanshijiekenengyoudezuixianjindeyiqishebeiquanyongshang,yebukenengjiangshengwuyaodejiegoudengtexingwanquanbiaozhengqingchu。zheixietedianyezhudingshengwuleisiyaobukenengwanquanheyuanyanyaoyimoyiyang,jishishitongyijiagongsishengchandetongyizhongshengwuyao,butongpiciyehuiyouchayi,jishishitongyipici,zaichucun、liutongdeguochengzhong,shengwuyao(youqishidanbaileiyaowu)dejiegouhehuoxingyebukebimiandehuiyousuobianhua。duiyushengwuleisiyaoshengchanshangeryan,youyuzhishichanquanbaohudengduozhongyuanyin,yuanyanyaogongsisuocaiyongdeshengchangongyishenzhishisuocaiyongdexibaoxidouhuibuqingchu,zheijiugengdaozhishengwuleisiyaoyuyuanyanyaobuhuiyiyang。lingwai,duiyushengwuyaoeryan,qishengchanjiliutongguochenggengjiafuza,yaoqiuyegenggao,youxuduobuzhou,xibaopeiyangdetiaojian(wenduheyingyang)、chanpindejiagong、chunhua、chucunhebaozhuangdenggegehuanjiedouhuiyingxiangchanpindeshengchan,zhenggeguochengzhongdeweixiaochabiedoukenenghuiduizuizhongchanpindezhiliang、chundu、shengwutexingyijilinchuangxiaoguochanshengjiaodadeyingxiang。zhengyouyushangshuzhongzhongyuanyin,suiranhuaxuefangzhiyaodeyingwenshigeneric drug,danshishengwuleisiyaobingfeishibiogeneric,ershibiosimilar,yinweishengwuleisiyaozhikenengyuyuanyanyao“xiangsi”(similar),juewukenengyiyang。


ranerduiyuchuantongdexiaofenzihuaxueyaoeryan,yibandouyoufeichangquedingerqiewendingdehuaxuejiegou,xianyoudefenxifangfa(biruhongwai、hecigongzhen、x-shexianyanshe、zhipudeng)zuyijiangqihuaxuejiegouwanquangaoqingchu。suoyi,zongdelaishuoshengwuyaodeshengchanduiyuqishengchantiaojiandeyaoqiuyuanbihuaxueyaokeke,dangranshengchanchengbenyegenggao,erqieshengwuyaodelinchuangqianhelinchuangjieduandeyanfachengbenyegenggao,yinweijianguanjigou(youqishizaioumei)yaoqiushengwuleisiyaoshengchanshangtigongzugoudelinchuangshujuchongfenzhengmingshengwuleisiyaoheyuanyanyaoyouyiyangdelinchuangliaoxiao,zheiyedaozhishengwuleisiyaozaihuopishangshiqiandefangzhichengbenwangwangshihuaxueyaodeshangbaibei。yezhengshiyouyushengwuleisiyaogaoangdefangzhichengbenheshengchanchengben,yibanshengwuleisiyaoheyuanyanyaoxiangbi,zhinengjiangjia10-30%,erhuaxuefangzhiyaozekegaoda80%shenzhigenggaodebili(zheiyidianduiyuyinduzhizaodehuaxuefangzhiyaoyouqiruci),suoyihuaxueyuanyanyaoyidanzhuanliguoqi,jiuhuishoudaofangzhiyaodemengliechongji,xiaoshouehuidafuduxiajiang,erhuaxuefangzhiyaoyehuihenkuaiqiangzhanshichang(zheiyidian,ciqiandeyaowangliputuolipitorjiushimingzheng),ershengwuyuanyanyaozezaizhuanliguoqihou,qixiaoliangshoufangzhiyaodeyingxiangjiaoxiao。shengwuyaohehuaxueyaodelingwaiyigezhongyaoqubieshitamendemianyiyuanxing,jihusuoyoudezhiliaoxingdanbaidouhuizairentineichanshengkangti。tamenhuitongguozhongheneiyuanxingyinzierjiangdihuolishenzhiyoufayanzhongdefuzuoyong。


shengwuleisiyaohehuaxuefangzhiyaolingwaiyigequbiehaifanyingzaishangshihoudejianguanshang,huaxuefangzhiyaoyouyuheyuanyanyaojiegouxiangtong,qiejiegoujiandan,oumeijianguanjigouyunxuyaojishikeyizizhuyonghuaxuefangzhiyaotihuanyuanyanyao(ji:zidongtihuanzhengce, huoketihuan, interchangeability),wuxutongzhikaichufangdeyisheng。erduiyushengwuleisiyao,zaioumeng,faguimingqueyaoqiubuyunxuzidongtihuan。jiumuqianmeiguofdayijingzhengshifabudeyouguanshengwuleisiyaodezhinanlaikan,biosimilaryoukeyifenweilianglei: 1)heyuanyanshengwuyaogaoduxiangsideputongbiosimilar; 2)  interchangeable biosimilar。


keyizidongtihuandeshengwuleisiyaobiputongshengwuleisiyaoyaoqiugengweiyange,qijinweizhifdacaipizhunleyigeshengwuleisiyao,qiebuyunxuzidongtihuan,bizheyujizhishaozaiweilaide3-5nianhennanyoukezidongtihuandeshengwuleisiyaozaimeiguohuopishangshi。


duiyuzidongtihuanzhengcebizherenweiyoubiyaoduoshuojiju:interchangeableqishiruguofanyichengzidongtihuanjiuhuizaochengqiyi,qishiinterchangeablebingbushizidonghuaxitongzhende“zidong”tihuande,ershigenjumeiguodefagui,yaodianhuoyiyuandeyaojishikeyigenjuzijidezhishihejingyanlaipanduanchufangyaoshifoukeyitihuan。yishangshumeiguoshengwuleisiyaodedumiao(ji2015nian3yuepizhundeshandeshide zarxio (filgrastim-sndz))weili,ruguoyigemeiguoyishengkaidechufangshianjindeneupogen,yaojishijiubunengzizuozhuzhangyongzarxiolaitihuan,yinweizarxiobushiinterchangeable biosimilar。erruguozarxioshiinterchangeable biosimilar,yaojishizekeyibuyongzhihuikaichufangdeyishengjiukeyiyongzarxiolaitihuanneupogen。rushangsuoshu,qijinweizhifdashangweipizhunrenheyizhonginterchangeable biosimilar。youyushengwuyaodegaodufuzaxing,shengwuleisiyaonengzuodaoheyuanyanyaogaoduleisiyijinghenburongyi,ruguoyaozuodaoheyuanyanyaoyiyangdeketihuandeshengwuleisiyaonandubushiyibandeda,dadaoshenmeyangdebiaozhuncaisuaninterchangeable biosimilar,muqianfdashangweichutaimingquedezhinan,xiangxinchutaizheiyangdezhinanyebushiyijianrongyideshi。


yinci,xiangjiaoyuhuaxueyao,gengjiafuzabingqietongchangyegengjiaangguideshengwuyaojinrushichangyemianlingengdadetiaozhan,youqishiduiyudishourushuipingdefazhanzhongguojiaeryan。muqianzaizhongguo,bentushengwuyao(juedaduoshushisuoweidediyiboshengwuleisiyao,ruganraosu、shengzhangyinzideng)zaizongdeyaowushichangsuozhanbilijiaoxiao,erzaioumei,huopidechuangxinshengwuyaoshuliangjinjinianjibenzhanhuopixinyaozongliangdesanchengzuoyou(zaimeiguo,ruguosuanshangfdaxiashucberpideshengwuyao,zheigebiligenggaoyixie),youyushengwuyaojiageyibangenggao,shengwuyaodeshichangfenezaiquanqiubuduankuaisushangsheng。jiuquanqiueryan,muqianshengwuleisiyaohaijibenchuyuqibujieduan,shengwuleisiyaomuqiansuozhanshichangfenekeyishuohaiweibuzudao,danshi,yejiepubianrenwei,weilai10-15nianshishengwuleisiyaodehuangjinfazhanqi,juyiyaolingyushijiedingjizixungongsiims healthyuce,zhi2020nian,shengwuleisiyaodenianxiaoshoueyouwangdadao250yimeiyuan,yuezhanshengwuyaoshichangfenede10%。yinci,mianduirucidadedangao,woguozuoweifangzhiyaodaguo,mianduiruciliangji,woguoyaoqiyoutiaojiandeziranyaoshangmashengwuleisiyao,meiyoutiaojiandexiangfangshefayeyaoshang,suoyixianzaiwoguozaiyanshengwuleisiyaoshuliang(zhuyaoshilinchuangqianjieduan)yijingchaoguomeiguo,chengweiquanqiudiyi(jutangsenlutoushuju),zheimeduoshengwuleisiyaoruguozhikaozhongguoshichang,xianranxiaohuabule,yihoujinjunoumeiguojishichangxiangxinhuishizhongguobentuyixieyoushiliyaoqidebiranxuanze。danshi,oumeiyouqishiquanqiuyaopindiyidashichangmeiguoduishengwuleisiyaodejianguanfeichangyange,suoyizhongguoyaoqidouzhinanertui,youqiduiyunanduzuidahanjinliangyezuigaodedankelongkangtideshengwuleisiyao,qijinmeiyouyigelaizizhongguodedankangshengwuleisiyaozaimeiguokaishilinchuangshiyan,zhenggedazhonghuadiquyezhiyoutaiwandexikang(jhl)naxiaouzhou,lvxianzaiouzhoukaishilinchuangshiyanzijiderituximabshengwuleisiyao(jilituoxidankang)jhl1101。


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shengming:benwenweizhuanzai,jingongfenxiangxuexizhiyong,budeyongyurenheshangyeyongtu,wenzhangbanquanguiyuanzuozhesuoyou。ruguosuoxuanneirongdewenzhangzuozherenweiqizuopinbuyigongdajialiulanhuozhebuyingwuchangshiyong,qingjishilianxi,womenjianghuijishishanchu。


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