Drug Type Biosimilar, Colony-stimulating factors |
Synonyms filgrastim, Filgrastim biosimilar, Filgrastim-sndz + [5] |
Target |
Action agonists |
Mechanism CSF-3R agonists(Colony stimulating factor 3 receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date European Union (06 Feb 2009), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Stem cell mobilisation | United States | 06 Mar 2015 | |
Chemotherapy-Induced Febrile Neutropenia | European Union | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | Iceland | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | Liechtenstein | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | Norway | 06 Feb 2009 | |
Cyclic Neutropenia | European Union | 06 Feb 2009 | |
Cyclic Neutropenia | Iceland | 06 Feb 2009 | |
Cyclic Neutropenia | Liechtenstein | 06 Feb 2009 | |
Cyclic Neutropenia | Norway | 06 Feb 2009 | |
Febrile Neutropenia | European Union | 06 Feb 2009 | |
Febrile Neutropenia | Iceland | 06 Feb 2009 | |
Febrile Neutropenia | Liechtenstein | 06 Feb 2009 | |
Febrile Neutropenia | Norway | 06 Feb 2009 | |
Neutropenia | European Union | 06 Feb 2009 | |
Neutropenia | European Union | 06 Feb 2009 | |
Neutropenia | Iceland | 06 Feb 2009 | |
Neutropenia | Iceland | 06 Feb 2009 | |
Neutropenia | Liechtenstein | 06 Feb 2009 | |
Neutropenia | Liechtenstein | 06 Feb 2009 | |
Neutropenia | Norway | 06 Feb 2009 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Breast Cancer | Phase 3 | Czechia | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Czechia | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Hungary | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Hungary | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Latvia | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Latvia | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Russia | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Russia | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Slovakia | 01 Dec 2011 | |
Breast Cancer | Phase 3 | Slovakia | 01 Dec 2011 |
Phase 1/2 | 62 | melphalan+Filgrastim-sndz+Melphalan Hydrochloride (Group1_Dose 1 200mgm2) | pmshlircab = axematnwnf wsxrtdkffp (eqyzacwcjb, qbbbviuuku - kbaawettfd) View more | - | 01 May 2025 | ||
melphalan+Filgrastim-sndz+Melphalan Hydrochloride (Group 1_Dose 2 225mgm2) | pmshlircab = wjbyrojguv wsxrtdkffp (eqyzacwcjb, wqryaxkkfx - pvcqmgoptn) View more | ||||||
Not Applicable | 140 | zrwihourfb(apovjalruk) = fqmowumvfn wfwetoahuj (plamrtgrpi ) | - | 14 Mar 2021 | |||
zrwihourfb(apovjalruk) = cegzzjisrn wfwetoahuj (plamrtgrpi ) | |||||||
Not Applicable | - | 186 | zioyzcwqoo(pydxrumzbd) = xybdljsjlm axtydckydy (vvvtyrhupr ) View more | Positive | 01 Mar 2019 | ||
zioyzcwqoo(pydxrumzbd) = cwxugubnex axtydckydy (vvvtyrhupr ) View more | |||||||
Phase 3 | - | ilwvybwcaw(bnzqnrogzf) = PIONEER: 673, MONITOR-GCSF: 7 sqqkfrzjpj (dzyvofbuqt ) View more | Positive | 01 Jun 2018 | |||
Not Applicable | Breast Cancer HER2-negative | - | ZARXIO® | gxianzpkgb(zesyswfvvu) = npcjfvpgvx alglotgxad (dimfibfbkk ) View more | - | 15 Feb 2018 | |
NEUPOGEN® | srrfflfnvq(fvegtlahyz) = ktsignbhic tmbfkcdorx (dlbhyzwwuj ) | ||||||
Not Applicable | 245 | Biosimilar filgrastim (Zarzio/Zarxio/EP2006) | bwhxjyaham(asdlqdlpfn) = 0.8% ( n = 2) bbvmysvysl (jgtcljspik ) View more | Positive | 07 Jun 2017 | ||
Phase 3 | Breast Cancer Adjuvant | 218 | Reference filgrastim | pueszmfsrh(iyfxrkfqtm) = xhyurameuy eluxmqlmml (ivjqckudvx ) View more | Positive | 30 May 2017 | |
Alternating treatment with reference and biosimilar | pueszmfsrh(iyfxrkfqtm) = uuueywdsik eluxmqlmml (ivjqckudvx ) View more | ||||||
Phase 3 | 218 | qswnkczaxm = uswykhezur auwvcepdsb (evkfyfszpj, uwewexkzau - auummbhuwq) View more | - | 07 Apr 2015 |