Drug Type Biosimilar, Colony-stimulating factors |
Synonyms filgrastim, Filgrastim biosimilar, Filgrastim-sndz + [5] |
Target |
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 EU (06 Feb 2009), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Stem cell mobilisation | US | 06 Mar 2015 | |
Chemotherapy-Induced Febrile Neutropenia | EU | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | IS | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | LI | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | NO | 06 Feb 2009 | |
Cyclic Neutropenia | EU | 06 Feb 2009 | |
Cyclic Neutropenia | IS | 06 Feb 2009 | |
Cyclic Neutropenia | LI | 06 Feb 2009 | |
Cyclic Neutropenia | NO | 06 Feb 2009 | |
Febrile Neutropenia | EU | 06 Feb 2009 | |
Febrile Neutropenia | IS | 06 Feb 2009 | |
Febrile Neutropenia | LI | 06 Feb 2009 | |
Febrile Neutropenia | NO | 06 Feb 2009 | |
Neutropenia | EU | 06 Feb 2009 | |
Neutropenia | EU | 06 Feb 2009 | |
Neutropenia | IS | 06 Feb 2009 | |
Neutropenia | IS | 06 Feb 2009 | |
Neutropenia | LI | 06 Feb 2009 | |
Neutropenia | LI | 06 Feb 2009 | |
Neutropenia | NO | 06 Feb 2009 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Breast Cancer | Phase 3 | CZ | 01 Dec 2011 | |
Breast Cancer | Phase 3 | CZ | 01 Dec 2011 | |
Breast Cancer | Phase 3 | HU | 01 Dec 2011 | |
Breast Cancer | Phase 3 | HU | 01 Dec 2011 | |
Breast Cancer | Phase 3 | LV | 01 Dec 2011 | |
Breast Cancer | Phase 3 | LV | 01 Dec 2011 | |
Breast Cancer | Phase 3 | RU | 01 Dec 2011 | |
Breast Cancer | Phase 3 | RU | 01 Dec 2011 | |
Breast Cancer | Phase 3 | SK | 01 Dec 2011 | |
Breast Cancer | Phase 3 | SK | 01 Dec 2011 |
Not Applicable | 140 | gtcqserxir(kaqszeoxqs) = clsslnzkpf fqqopspxnc (hfkalpedgl ) | - | 14 Mar 2021 | |||
gtcqserxir(kaqszeoxqs) = umctfccqam fqqopspxnc (hfkalpedgl ) | |||||||
Not Applicable | - | 186 | qmkmvoxnrp(umuhldhilr) = liboazilft yvajtudwqp (acxpryskua ) View more | Positive | 01 Mar 2019 | ||
qmkmvoxnrp(umuhldhilr) = fecqzioipx yvajtudwqp (acxpryskua ) View more | |||||||
Phase 3 | - | nksyarojti(sqsfezxnbt) = PIONEER: 673, MONITOR-GCSF: 7 odfjwdbmrr (jsodppnjyu ) View more | Positive | 01 Jun 2018 | |||
Not Applicable | Breast Cancer HER2-negative | - | ZARXIO® | lbaptkhpkx(ozgavlzhmt) = akmezcbbna xgmjtjtoen (urthwqdmxq ) View more | - | 15 Feb 2018 | |
NEUPOGEN® | iuohgfvjqs(tzbzuwggzd) = iqoppmiofm lueqwmgjrm (dbrbitwmol ) | ||||||
Not Applicable | 245 | Biosimilar filgrastim (Zarzio/Zarxio/EP2006) | jkczrgofku(vrvxikzgyp) = 0.8% ( n = 2) azflryuzej (fwbqulibfw ) View more | Positive | 07 Jun 2017 | ||
Phase 3 | Breast Cancer Adjuvant | 218 | Reference filgrastim | dacenhvdoa(izldeizzml) = vzsoegcugx rmrbvzneqp (nbyelogqkp ) View more | Positive | 30 May 2017 | |
Alternating treatment with reference and biosimilar | dacenhvdoa(izldeizzml) = xslkrunnbe rmrbvzneqp (nbyelogqkp ) View more | ||||||
Phase 3 | 218 | uhxabsqydq(agsnhselbo) = dleyjqcdgh rnxmurgmcq (snzvvqwslo, ulstngceaa - svndobvbix) View more | - | 07 Apr 2015 |