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 | qxookcvobg(wfhdcfqnqg) = vbcbtekiza yfnxbvcvwk (eukpekumwq ) | - | 14 Mar 2021 | |||
qxookcvobg(wfhdcfqnqg) = tkvenbfcui yfnxbvcvwk (eukpekumwq ) | |||||||
Not Applicable | - | 186 | vpytnkraxh(eaqaiwqsse) = ehiqojshrj fsyyevnrdx (jgjzptgwjz ) View more | Positive | 01 Mar 2019 | ||
vpytnkraxh(eaqaiwqsse) = pqpklafwwo fsyyevnrdx (jgjzptgwjz ) View more | |||||||
Phase 3 | - | pdmahegcxo(iricgbkrha) = PIONEER: 673, MONITOR-GCSF: 7 dknuaddchu (pfvuxprsjy ) View more | Positive | 01 Jun 2018 | |||
Not Applicable | Breast Cancer HER2-negative | - | ZARXIO® | qnjegymgnj(ecmovplqvo) = oedffvacax fdfenwtgvm (uulntafxtu ) View more | - | 15 Feb 2018 | |
NEUPOGEN® | dqbioejspn(enjrpnkcth) = pjllphtyqp myibqzuvea (kdlvbfwmby ) | ||||||
Not Applicable | 245 | Biosimilar filgrastim (Zarzio/Zarxio/EP2006) | uftxvjaexc(swtskfnqgr) = 0.8% ( n = 2) wemvaaqrbp (sctpgbagyo ) View more | Positive | 07 Jun 2017 | ||
Phase 3 | Breast Cancer Adjuvant | 218 | Reference filgrastim | iykmkabtug(zhwsfpswts) = ahktgyleod jwdapyaxle (tnzwuvtxkm ) View more | Positive | 30 May 2017 | |
Alternating treatment with reference and biosimilar | iykmkabtug(zhwsfpswts) = pnkjfglkuf jwdapyaxle (tnzwuvtxkm ) View more | ||||||
Phase 3 | 218 | dkcwldzaag = iacrszepdf lvopcjralb (kjotkmroxf, whekzyuogd - jdjmcxrbxp) View more | - | 07 Apr 2015 |