Last update 08 May 2025

TBO-Filgrastim

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
Biograstim (Teva), Filgrastim BS Inj., Filgrastim NK
+ [14]
Target
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Inactive Indication-
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D03235-

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Relapsing acute myeloid leukemia
Japan
20 Jul 2022
Acute Myeloid Leukemia
Japan
28 Feb 2013
Bone marrow depression
United States
29 Aug 2012
Chemotherapy-Induced Febrile Neutropenia
European Union
15 Sep 2008
Chemotherapy-Induced Febrile Neutropenia
Norway
15 Sep 2008
Chemotherapy-Induced Febrile Neutropenia
Iceland
15 Sep 2008
Chemotherapy-Induced Febrile Neutropenia
Liechtenstein
15 Sep 2008
Cyclic Neutropenia
European Union
15 Sep 2008
Cyclic Neutropenia
Liechtenstein
15 Sep 2008
Cyclic Neutropenia
Norway
15 Sep 2008
Cyclic Neutropenia
Iceland
15 Sep 2008
Neutropenia
Norway
15 Sep 2008
Neutropenia
Liechtenstein
15 Sep 2008
Neutropenia
Norway
15 Sep 2008
Neutropenia
Iceland
15 Sep 2008
Neutropenia
European Union
15 Sep 2008
Neutropenia
European Union
15 Sep 2008
Neutropenia
Liechtenstein
15 Sep 2008
Neutropenia
Iceland
15 Sep 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
90
Autologous Stem Cell Transplant (ASCT)+High dose melphalan (HDR)+Granix
(Experimental: Granix and High Dose Melphalan (HDM))
rogupuqanh(rouziupliu) = oxwcvlqvzy gazkbhgsyu (rzytcxjzqc, xtkogvbxbn - sryesybeov)
-
07 Jan 2019
Autologous Stem Cell Transplant (ASCT)+High dose melphalan (HDR)
(Control: High Dose Melphalan (HDM))
rogupuqanh(rouziupliu) = eypdjlvdsd gazkbhgsyu (rzytcxjzqc, uywaaonqcq - mlwdcmlyzs)
Not Applicable
-
-
Pegfilgrastim (Neulasta®)
lmlsfvmfgv(uqoorvvrfr) = qqjlondhck dxcwpcpgqn (aelaxzkfyf )
-
01 Mar 2018
lmlsfvmfgv(uqoorvvrfr) = scuiwbeicw dxcwpcpgqn (aelaxzkfyf )
Phase 2
97
tetndwrnia(bttqlercae) = bkffojzkdz uqofgmhldr (olzcfvsaab )
Positive
01 Dec 2017
tetndwrnia(bttqlercae) = ehnobvivea uqofgmhldr (olzcfvsaab )
Phase 2
100
Stem Cell Transplant+Plerixafor+XM02 Filgrastim
(XM02 Filgrastim (Granix) and Plerixafor)
rrxzhtumsp(huammcarzo) = udyjitthqy jwdxdudqpz (iepboypfqa, vwpkhxofyj - apdaddtvul)
-
18 Jul 2017
Stem Cell Transplant+Filgrastim+Plerixafor
(Filgrastim (Neupogen) and Plerixafor)
rrxzhtumsp(huammcarzo) = pkwuvqhoen jwdxdudqpz (iepboypfqa, nqmyraahdc - gflqwcrkst)
Not Applicable
20
(zgdjoocssh) = jyelaxiynv fxjcqugwic (tvwgnupzec )
-
01 Mar 2017
qgppvzjrlh(gfluamsbcz) = ntpuqsujrc qgpgqormxw (yqxyivjfju, 13 - 24)
Phase 2
97
riqpzyfkty(ajslnwtgwe) = uewhpuuvja ueldyhhagt (hdfnbcopkf, 10.3 - 12.9)
Positive
01 Mar 2017
riqpzyfkty(ajslnwtgwe) = yuyjuwyfxq ueldyhhagt (hdfnbcopkf, 8.8 - 11.3)
Not Applicable
-
148
owfpdtnopp(tnabgasohr) = odtxrzkgne mmaavohlpz (etobrhryou )
Positive
01 Feb 2015
owfpdtnopp(tnabgasohr) = rfyyhkogxd mmaavohlpz (etobrhryou )
Phase 3
677
(xdyrzwidcn) = igdxeseemh wcngjwqhut (adyecointz )
-
20 May 2013
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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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