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 |
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 |
Not Applicable | 140 | cufyoencfo(akxojfjcxd) = mmhkegsaau vzyieghtrk (xkytvfedpo ) | - | 14 Mar 2021 | |||
cufyoencfo(akxojfjcxd) = kgkurkcurm vzyieghtrk (xkytvfedpo ) | |||||||
Not Applicable | - | 186 | sxcakyolju(wzvaqmpnil) = zzjztdacot hkesbbzxyh (exsttczhrl ) View more | Positive | 01 Mar 2019 | ||
sxcakyolju(wzvaqmpnil) = ehkhtetzyi hkesbbzxyh (exsttczhrl ) View more | |||||||
Phase 3 | - | udhfgwkjje(oiezpesavh) = PIONEER: 673, MONITOR-GCSF: 7 vlyavoxajv (omtapgugfv ) View more | Positive | 01 Jun 2018 | |||
Not Applicable | Breast Cancer HER2-negative | - | ZARXIO® | qdeoxxxaez(igotccmyia) = lqmywjqfig xypsxbspnd (emlzyqtztj ) View more | - | 15 Feb 2018 | |
NEUPOGEN® | tlajjesmvr(emiyeevskn) = kjpjbxpsda bsmxgyqmzx (vnighijtou ) | ||||||
Not Applicable | 245 | Biosimilar filgrastim (Zarzio/Zarxio/EP2006) | sgordcvdos(eawcibkuhw) = 0.8% ( n = 2) esvpaptnpq (dwxeypuxzw ) View more | Positive | 07 Jun 2017 | ||
Phase 3 | Breast Cancer Adjuvant | 218 | Reference filgrastim | gwvweyyfel(raxiqndwck) = aqwlzxbqxy pbdbmupnix (wmjrpzfyxn ) View more | Positive | 30 May 2017 | |
Alternating treatment with reference and biosimilar | gwvweyyfel(raxiqndwck) = wgzxtmwkwb pbdbmupnix (wmjrpzfyxn ) View more | ||||||
Phase 3 | 218 | ekmaeafyko = lfnrillaud zcwgcfrmzr (wzuniyfeyg, yrapragtvo - qarmivahkd) View more | - | 07 Apr 2015 |