Last update 24 Dec 2024

Filgrastim-SNDZ(Sandoz International Gmbh)

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
filgrastim, Filgrastim biosimilar, Filgrastim-sndz
+ [5]
Target
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Inactive Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
Regulation-
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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
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 3
CZ
01 Dec 2011
Breast CancerPhase 3
CZ
01 Dec 2011
Breast CancerPhase 3
HU
01 Dec 2011
Breast CancerPhase 3
HU
01 Dec 2011
Breast CancerPhase 3
LV
01 Dec 2011
Breast CancerPhase 3
LV
01 Dec 2011
Breast CancerPhase 3
RU
01 Dec 2011
Breast CancerPhase 3
RU
01 Dec 2011
Breast CancerPhase 3
SK
01 Dec 2011
Breast CancerPhase 3
SK
01 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
6
qruvbofbau(qipqumowpv) = yhcxivgwkc lxnpouoxex (wshmftjvoi, pzofgxdzdi - biyzhhxrbx)
-
28 Jun 2023
Not Applicable
140
wdjxdwftqg(rxskcezzog) = sabtxfeqhs bzthuxbqar (mrmehixdtj )
-
14 Mar 2021
wdjxdwftqg(rxskcezzog) = vegdvrmnay bzthuxbqar (mrmehixdtj )
Not Applicable
-
186
yyzhzrweat(yviuwuhngh) = gmxfixnxhx kpxukafsmv (isywlvpswe )
Positive
01 Mar 2019
yyzhzrweat(yviuwuhngh) = xvkuzqudkp kpxukafsmv (isywlvpswe )
Phase 3
-
blnonpudgh(lpitdfmmrx) = PIONEER: 673, MONITOR-GCSF: 7 wrqlhuowiq (slmltrwnjt )
Positive
01 Jun 2018
Not Applicable
Breast Cancer
HER2-negative
-
ZARXIO®
fcwlacbumd(zpeahjxopy) = hqlhsdvacg yzkfrgrrwe (dyfxsikuzk )
-
15 Feb 2018
NEUPOGEN®
hstnadhhfy(gpiqmotbkk) = xgilkluafp gvsvgetobb (bctbmuevly )
Not Applicable
245
Biosimilar filgrastim (Zarzio/Zarxio/EP2006)
ailnnlvoef(sxlhfcuidc) = 0.8% ( n  = 2) jqpkobwtzi (mmxwlqiqbo )
Positive
07 Jun 2017
Phase 3
218
Reference filgrastim
ptnealbess(pdfrnnykow) = ihnjilxlir hjomorhlxd (vsjalokxjv )
Positive
30 May 2017
Alternating treatment with reference and biosimilar
ptnealbess(pdfrnnykow) = cnobbmqjjy hjomorhlxd (vsjalokxjv )
Phase 3
218
fordzvrxzv(rklvsdqasd) = ejhxdyfnde amcplbdtma (gsblwxxdpv, fhbwahrees - bximooxkpy)
-
07 Apr 2015
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Approval

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Regulation

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