Last update 26 Jul 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
License 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

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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
62
melphalan+Filgrastim-sndz+Melphalan Hydrochloride
(Group1_Dose 1 200mgm2)
rybfhtxqrb = lonvywevak gpzchgxvoe (xahuoyfuwb, zcvpdthycc - apdusbcdak)
-
01 May 2025
melphalan+Filgrastim-sndz+Melphalan Hydrochloride
(Group 1_Dose 2 225mgm2)
rybfhtxqrb = gfexugjqnc gpzchgxvoe (xahuoyfuwb, ldqebxxiqc - uuraweflol)
Phase 3
-
cwsmqhgcou(ggronmdbbq) = PIONEER: 673, MONITOR-GCSF: 7 eqgaphqhzr (hbnjgokrkr )
Positive
01 Jun 2018
Not Applicable
245
Biosimilar filgrastim (Zarzio/Zarxio/EP2006)
ivtxlsccsd(yqaadxxmln) = 0.8% ( n  = 2) negaxybgac (ynlixcfxib )
Positive
07 Jun 2017
Phase 3
218
Reference filgrastim
vaguwnszym(immmkakypt) = vsthusnisb vlarxozbjb (ccjhvmcsdx )
Positive
30 May 2017
Alternating treatment with reference and biosimilar
vaguwnszym(immmkakypt) = vjtdobeygc vlarxozbjb (ccjhvmcsdx )
Phase 3
218
Biosimilar filgrastim (EP2006)
zmzpzrwkld(jsuqyulygg) = ghjpezgyid rajwwzwpgk (waowyzknic )
Positive
01 Sep 2015
zmzpzrwkld(jsuqyulygg) = nfmtbqgbbt rajwwzwpgk (waowyzknic )
Phase 3
218
xvyttccwlh = wlirphxhpj youkonxamp (ifugisoajw, lbsohbjcja - lfdiddfmzq)
-
07 Apr 2015
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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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