Last update 24 Mar 2025

Filgrastim-SNDZ(Sandoz International Gmbh)

Overview

Basic Info

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)
Inactive Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 3
Czechia
01 Dec 2011
Breast CancerPhase 3
Czechia
01 Dec 2011
Breast CancerPhase 3
Hungary
01 Dec 2011
Breast CancerPhase 3
Hungary
01 Dec 2011
Breast CancerPhase 3
Latvia
01 Dec 2011
Breast CancerPhase 3
Latvia
01 Dec 2011
Breast CancerPhase 3
Russia
01 Dec 2011
Breast CancerPhase 3
Russia
01 Dec 2011
Breast CancerPhase 3
Slovakia
01 Dec 2011
Breast CancerPhase 3
Slovakia
01 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
140
qxookcvobg(wfhdcfqnqg) = vbcbtekiza yfnxbvcvwk (eukpekumwq )
-
14 Mar 2021
qxookcvobg(wfhdcfqnqg) = tkvenbfcui yfnxbvcvwk (eukpekumwq )
Not Applicable
-
186
vpytnkraxh(eaqaiwqsse) = ehiqojshrj fsyyevnrdx (jgjzptgwjz )
Positive
01 Mar 2019
vpytnkraxh(eaqaiwqsse) = pqpklafwwo fsyyevnrdx (jgjzptgwjz )
Phase 3
-
pdmahegcxo(iricgbkrha) = PIONEER: 673, MONITOR-GCSF: 7 dknuaddchu (pfvuxprsjy )
Positive
01 Jun 2018
Not Applicable
Breast Cancer
HER2-negative
-
ZARXIO®
qnjegymgnj(ecmovplqvo) = oedffvacax fdfenwtgvm (uulntafxtu )
-
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 )
Positive
07 Jun 2017
Phase 3
218
Reference filgrastim
iykmkabtug(zhwsfpswts) = ahktgyleod jwdapyaxle (tnzwuvtxkm )
Positive
30 May 2017
Alternating treatment with reference and biosimilar
iykmkabtug(zhwsfpswts) = pnkjfglkuf jwdapyaxle (tnzwuvtxkm )
Phase 3
218
dkcwldzaag = iacrszepdf lvopcjralb (kjotkmroxf, whekzyuogd - jdjmcxrbxp)
-
07 Apr 2015
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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