Pfizer Lub Biosimilar Nyvepria (pefegrastim) Tau Pom Zoo Los Ntawm Asmeskas FDA!

Pfizer nyuam qhuav tshaj tawm tias Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tau pom zoo Nyvepria (pegfilgrastim-apgf), uas yog biosimilar rau Amgen' s blockbuster" litre dawb" hom tshuaj Neulasta (pegfilgrastim). Nyvepria yog qhov tsim nyog rau txo qis kev tshwm sim ntawm febrile neutropenia, uas yog ib qho kev mob tshwm sim hnyav tshaj plaws ntawm ntau yam kev kho mob rau tshuaj thiab tuaj yeem txo lub peev xwm ntawm cov neeg mob qog nqaij hlav los tiv thaiv kev kis mob.

Thaum Lub Xya Hli 2018, Pfizer' s ntxiv lwm qhov biosimilar, Nivestym (filgrastim-aafi), tau pom zoo los ntawm Asmeskas FDA. Cov tshuaj yog biosimilar ntawm Amgen' s" Shengbai" hom tshuaj Neupogen (filgrastim).

Kev pom zoo ntawm FDA ntawm Nyvepria yog saib raws li kev rov ntsuam xyuas ntawm pob cov ntaub ntawv ntxaws thiab tag nrho cov ntawv pov thawj los ua pov thawj tias Nyvepria zoo heev rau cov khoom siv Neulasta. Pfizer tseem tau xa daim ntawv thov kev lag luam rau pegfilgrastim biosimilar rau European Chaw Tshuaj Tshuaj (EMA), uas tam sim no tau tshuaj xyuas.

Andy Schmeltz, Pfizer Ntiaj Teb Thawj Tswj Hwm ntawm Oncology, tau hais tias: "FDA pom zoo ntawm Nyvepria yog ib kauj ruam zoo uas tuaj yeem txuag tau nqi thiab nce kev nkag mus rau cov kev xaiv tseem ceeb. Peb txaus siab los qhia qhov tshiab no, kev pab txhawb nqa lub sijhawm ntev ntxiv Ntxiv rau peb cov khoom lag luam muaj zog, tam sim no muaj rau qib FDA-pom zoo qog biosimilars, peb qhov kev pom zoo tshwj xeeb rau kev txhawb nqa kev saib xyuas ntawm cov neeg mob qog ntshav. Peb tos ntsoov yuav qhia rau Asmeskas cov neeg mob thiab cov kws kho mob xyoo tom qab xyoo no Qhia Nyvepria."

Ali McBride, yav tas los tus thawj tswj hwm ntawm Community Cancer Center Association (ACCC), tau hais tias:" Fevery neutropenia tshwm sim los ntawm kev siv tshuaj kho mob yog ib qho muaj thiab kev mob tshwm sim tsis zoo hauv qee cov kev kho mob qog noj ntshav, uas yuav ua rau mob hnyav thiab tuaj yeem ua rau cov kev xaiv kho. Hloov. Kev pom zoo ntawm FDA ntawm Nyvepria yuav muab cov kws kho mob nrog cov phiaj xwm kev kho mob mus sij hawm ntev uas tuaj yeem pab tiv thaiv kev sib kis kab mob hauv cov neeg mob myelosuppressive chemotherapy."

Biosimilars ua si lub luag haujlwm tseem ceeb hauv kev kho mob qog noj ntshav lossis txhawb kev saib xyuas. Nws tsis tsuas yog pab txhawm rau txhim kho cov neeg mob' nkag mus rau cov tshuaj yooj yim, tab sis kuj txhawb nqa kev sib tw ua lag luam, txo nqi kho mob, thiab muab tus nqi rau kev kho mob.

Pfizer muaj ntau tshaj li kaum xyoo ntawm kev ua lag luam thoob ntiaj teb hauv biosimilars, nrog 9 lub chaw tso cai biosimilar cov khoom lag luam nyob hauv Tebchaws Meskas thiab qhov dav tshaj plaws ntawm biosimilars los pab kho mob cancer. Pfizer zoo siab los ua tus thawj coj biosimilar Ntiaj teb ua thawj coj hauv daim teb, thiab ua tus thawj coj hauv thaj chaw kho mob tseem ceeb no.

pegfilgrastim yog kev ua yeeb yaj kiab ntev ntev ntawm filgrastim (recombinant tib neeg cov granulocyte macrophage colony stimulating factor [G-CSF]), uas tau hloov kho los ntawm polyethylene glycol (PEG) kom ntev lub sij hawm metabolic ntawm cov tshuaj hauv lub cev thiab muaj cov txiaj ntsig zoo dua. Ob qhov tshuaj yog" whitening" tshuaj, siv los txhim kho cov qe ntshav dawb hauv cov neeg mob. G-CSF feem ntau yog siv rau kev tiv thaiv thiab kev kho mob leukopenia los ntawm kev mob qog nqaij hlav los yog tshuaj kho mob, kho pob txha caj qaum hematopoietic tsis ua hauj lwm thiab myelodysplastic syndrome, tiv thaiv kev mob tshwm sim ntawm leukopenia, thiab kev nruab nrab los ntawm kev kis mob rov qab los ntawm neutropenia yog nrawm. Tom qab tshuaj tua hluav taws xob los yog kev siv tshuaj kho mob, cov neeg mob qog feem ntau muaj cov tsos mob xws li leukopenia thiab txo qhov muaj peev xwm tiv thaiv kev kis mob. Yog li ntawd, kev siv tshuaj rau" kho cov tshuaj" kom nce cov qe ntshav dawb hauv cov neeg mob.

Neutropenia yog ib qho mob loj heev ntawm kev siv tshuaj khomob. Cov kev tshawb fawb pom tau tias hauv Tebchaws Asmeskas, 4,000 tus neeg mob qog nqaij hlav tuag los ntawm febrile neutropenia txhua xyoo, thiab 60,000 tus neeg tau mus pw hauv tsev kho mob rau neutropenia. Hauv 10 xyoo tom ntej no, biosimilars xav tias yuav khaws ntau txog $ 54 nphom hauv Asmeskas cov kws kho mob. Muaj kev xav tau sai rau ntau txoj kev kho mob neutropenia hauv kev ua lag luam no vim hais tias mob cancer-txog neutropenia Cov nqi pw hauv tsev kho mob txhua xyoo yog siab li $ 2.3 nphom.

Raws li FDA cov ntaub ntawv ntawm biosimilars, raws li tam sim no, lub koom haum tau pom zoo ob daim ntawv biosimilars, uas yog: Nivestym (filgrastim-aafi, Lub Xya hli ntuj 2018, Pfizer), Zarxio (filgrastim-sndz, 2015 3 Lub Hlis, Sandoz).

Ntxiv rau, FDA tau pom zoo plaub biosimilars ntawm pefigrastim: Nyvepria (pegfilgrastim-apgf, Lub Rau Hli 2020, Pfizer), Fulphila (pegfilgrastim-jmdb, Lub Rau Hli 2018, Mylan), Udenyca (pegfilgrastim-cbqv, Kaum Ib Hlis 2018, Coherus BioSciences) (pegfilgrastim-bmez, Kaum Ib Hlis 2019, Sandoz).