Teb chaws Europe thawj biosimilar rau insulin aspart! Sanofi Insulin aspart Sanofi® pom zoo

Sanofi tau tshaj tawm tsis ntev los no hais tias European Commission (EC) tau pom zoo Insulin aspart Sanofi® (insulin aspart, insulin aspart, 100 units / ml) rau hom 1 hnub nyoog ≥1 xyoos thiab xav kom muaj insulin tswj ntshav qab zib cov menyuam, cov tub ntxhais hluas, thiab cov laus nrog ntshav qab zib thiab ntshav qab zib hom 2, suav nrog cov uas nyuam qhuav tab tom paub tias muaj ntshav qab zib.

Cov kev txiav txim siab no tau txiav txim siab tom qab Pawg Neeg Saib Xyuas Kev Noj Tshuaj Hauv Tebchaws (EMA) rau Cov Khoom Kho Mob Tib Neeg (CHMP) tau muab kev tshuaj xyuas zoo. Cov khoom no yuav muab lwm txoj kev kho mob rau cov neeg mob ntshav qab zib uas xav tau insulin aspart.

Insulin aspart Sanofi® yog biosimilar ntawm NovoRapid (hom tshuaj npe: NovoRapid, cov npe dav dav: insulin aspart, insulin aspart), insulin ua haujlwm sai ntawm Novo Nordisk (Novo Nordisk), ob yam khoom muaj txiaj ntsig zoo, muaj kev nyab xeeb thiab ua tau zoo Cov. NovoRapid yog cov tshuaj noj rau hauv lub sijhawm insulin analogue uas tsim nyog rau kev kho mob ntshav qab zib rau cov laus, cov hluas, thiab cov menyuam yaus hnub nyoog 1 xyoos thiab laus dua. Tsis tas li, NovoRapid kuj tseem tuaj yeem siv rau hauv cov poj niam cev xeeb tub los kho ntshav qab zib hauv cov poj niam cev xeeb tub. Hauv Tebchaws Europe, NovoRapid tau pom zoo rau cov npe thaum Lub Cuaj Hlis 7, 1999.

Nws tsim nyog teev tias Insulin aspart Sanofi® yog thawj biosimilar insulin aspart tau pom zoo los ntawm European Union, uas ua tiav Sanofi cov tshuaj insulin cov khoom lag luam dav dav, suav nrog 2 lub vev xaib insulin sai uas tau pom zoo los ntawm EU lub koom haum tswj hwm.

EC pom zoo rau Insulin aspart Sanofi®, raws li cov ntaub ntawv los ntawm phiaj xwm kev txhim kho mob. Txoj haujlwm muaj ntau tshaj 600 tus neeg mob cov neeg mob hom 1 lossis ntshav qab zib hom 2. Peb tes num suav nrog cov theem I pharmacokinetic / pharmacodynamic (PK / PD) kawm txog kev ntsuas qhov sib luag ntawm cov khoom hauv cov ntsiab lus ntawm kev sib kis thiab kev ua haujlwm, thiab ntau qhov chaw theem IIIa cov chaw kuaj sim (Gemelli 12) ntsuas nws txoj kev ruaj ntseg thiab ua haujlwm tau zoo.

Hauv txhua qhov kev tshawb fawb, Insulin aspart Sanofi® tau sib piv nrog NovoRapid (100 units / ml) insulin aspart cov khoom lag luam tam sim no tau pom zoo los ntawm Asmeskas thiab EU rau kev siv rau cov neeg laus muaj ntshav qab zib hom 1 lossis hom 2. Cov ntaub ntawv los ntawm Ntu Kuv kawm paub tseeb tias Insulin aspart Sanofi® zoo ib yam li NovoRapid hauv pharmacokinetics (PK) thiab pharmacodynamics (PD); Kev Tshawb Nrhiav Ntu IIa tau lees tias qhov kev ua kom lub plawv ntshav qab zib thiab kev ua tau zoo ntawm 2 yam khoom thaum 26-lub lim tiam kho lub sijhawm kev ruaj ntseg kuj zoo ib yam.