Last update 25 Mar 2025

TBO-Filgrastim

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
Biograstim (Teva), filgrastim, Filgrastim biosimilar
+ [14]
Target
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Inactive Indication-
Inactive 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
Iceland
15 Sep 2008
Chemotherapy-Induced Febrile Neutropenia
Liechtenstein
15 Sep 2008
Chemotherapy-Induced Febrile Neutropenia
Norway
15 Sep 2008
Cyclic Neutropenia
European Union
15 Sep 2008
Cyclic Neutropenia
Iceland
15 Sep 2008
Cyclic Neutropenia
Liechtenstein
15 Sep 2008
Cyclic Neutropenia
Norway
15 Sep 2008
Neutropenia
European Union
15 Sep 2008
Neutropenia
European Union
15 Sep 2008
Neutropenia
European Union
15 Sep 2008
Neutropenia
Iceland
15 Sep 2008
Neutropenia
Iceland
15 Sep 2008
Neutropenia
Iceland
15 Sep 2008
Neutropenia
Liechtenstein
15 Sep 2008
Neutropenia
Liechtenstein
15 Sep 2008
Neutropenia
Liechtenstein
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))
dxsfhqpfiy = qkjryapxff erwdbyllai (fcupffolbd, zhuvdtitrt - yhljbajlhw)
-
07 Jan 2019
Autologous Stem Cell Transplant (ASCT)+High dose melphalan (HDR)
(Control: High Dose Melphalan (HDM))
dxsfhqpfiy = thiqtnrrmy erwdbyllai (fcupffolbd, acfdbuaflb - maffdnmubz)
Not Applicable
-
11
Paclitaxel/TBO-GCSF/Plerixafor
kkbasxotap(urzhcfqwwg) = gfqzcmicyn nxswttmwaa (emctvmqtlz )
Positive
01 Mar 2018
Phase 2
97
bpnfbovwbr(dgprfpfntu) = rexiiqgjzi gmcnybkyzk (lvlpvvcwnu )
Positive
01 Dec 2017
bpnfbovwbr(dgprfpfntu) = jwkgwuwxpp gmcnybkyzk (lvlpvvcwnu )
Phase 2
100
Stem Cell Transplant+Plerixafor+XM02 Filgrastim
(XM02 Filgrastim (Granix) and Plerixafor)
tlpkifgghc(yqigbnsmju) = tatjlfxvau niitfdfnqg (achfhjojoq, 6.7)
-
18 Jul 2017
Stem Cell Transplant+Filgrastim+Plerixafor
(Filgrastim (Neupogen) and Plerixafor)
tlpkifgghc(yqigbnsmju) = akidaqmqmu niitfdfnqg (achfhjojoq, 6.8)
Not Applicable
-
86
4 days Tbo-filgrastim
ojtayspbjf(dezbcsixap) = jquebpjicu smjvlxjsjx (wlbnoswcde )
-
01 Mar 2017
5 days Tbo-filgrastim
ojtayspbjf(dezbcsixap) = rxhpieylnl smjvlxjsjx (wlbnoswcde )
Not Applicable
20
nhjbhibilh(mdymrbycug) = sjgxqeejpo rmnuphrcpn (wapuepolzt )
-
01 Mar 2017
pzzdggbtrl(oahrhciayp) = efvziewxrg jmxflkmivs (kbqxlrgmhy, 13 - 24)
Phase 2
97
sruirtuuhe(inwpyuewhb) = htcwumlyep trixqquttx (ziezpowoob, 10.3 - 12.9)
Positive
01 Mar 2017
sruirtuuhe(inwpyuewhb) = anvjyfaahd trixqquttx (ziezpowoob, 8.8 - 11.3)
Not Applicable
-
148
mhmnvjdvec(wyntmrvaew) = gvtbnlnhix pclthvjksa (ooadahscnx )
Positive
01 Feb 2015
mhmnvjdvec(wyntmrvaew) = xxusotydbm pclthvjksa (ooadahscnx )
Phase 3
677
fvrlwxmvbx(iwfzpfmgte) = ayqivmwrgm buqhixmlgp (hdvfxyhnlt )
-
20 May 2013
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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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