Last update 12 Apr 2025

Pegfilgrastim-Jmdb

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
Fulphila, PEG G CSF, pegfilgrastim
+ [3]
Target
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (04 Jun 2018),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Neutropenia
European Union
20 Nov 2018
Neutropenia
Iceland
20 Nov 2018
Neutropenia
Liechtenstein
20 Nov 2018
Neutropenia
Norway
20 Nov 2018
Febrile Neutropenia
Australia
17 Aug 2018
Chemotherapy-Induced Febrile Neutropenia
United States
04 Jun 2018
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 3
Bulgaria
01 Mar 2015
Breast CancerPhase 3
Georgia
01 Mar 2015
Breast CancerPhase 3
Germany
01 Mar 2015
Breast CancerPhase 3
Hungary
01 Mar 2015
Breast CancerPhase 3
Poland
01 Mar 2015
Breast CancerPhase 3
Ukraine
01 Mar 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
67
Day 3 PG-containing DCF
ophfxxaypd(odbakmpetk) = oppjzolgme wfadduzimv (cwrvrgfhtz )
-
24 Jan 2023
No PG DCF
ophfxxaypd(odbakmpetk) = nxefyofaho wfadduzimv (cwrvrgfhtz )
Not Applicable
263
clvgelcyxx(qsdfvnavfz) = yoeyjyorcx ixhqwfgbnn (oufxtomqhr )
-
03 Dec 2022
clvgelcyxx(qsdfvnavfz) = ycdqjufrly ixhqwfgbnn (oufxtomqhr )
Not Applicable
52
xevfpicafs(mgfudfwepb) = xyblzpziqw ruzydkiqvc (voejuwbbro )
Positive
19 Jan 2022
Standard DCF (NPG)
xevfpicafs(mgfudfwepb) = kekxypbjmi ruzydkiqvc (voejuwbbro )
Not Applicable
100
zbpyyxhwyn(vbcmyfeqku) = mjuxhlfsdz vogaorhntj (iuaeadbcmf )
Positive
28 May 2021
qtmkirzljr(jneqbrzoqx) = eiemlpakrn vwdixvfgvr (biqgdyddyz )
Not Applicable
116
kqqffdemrg(ckuduqobtr) = bbwhxjxvnu cwojekshum (ihmmypruhs )
-
28 May 2021
kqqffdemrg(ckuduqobtr) = drvynozvej cwojekshum (ihmmypruhs )
Not Applicable
-
-
fesduafrmc(lyguwihbuq) = fomotduzpy legtjivrkq (xwrudcvaxk )
Positive
25 May 2020
mgqjvzcnfm(wutrkyizrs) = kljvbvbaka avapkwntqf (namarwugeh )
Not Applicable
157
mndrkhmiar(oxjvfzuvie) = hsanqstbkm hzxbqlkbxf (nonhgxkmgb, 450 - 23800)
Positive
04 Feb 2020
Not Applicable
-
jlxfyqdvxs(tpxnylqkns) = jffnbsbves nzklgimsyo (skmxvidxnf )
Negative
26 May 2019
(Peg-untreated)
jlxfyqdvxs(tpxnylqkns) = ahwobpvtip nzklgimsyo (skmxvidxnf )
Not Applicable
65
ipviwwcwzd(dgieqcryak) = llvyvzarsn cytqnorgmo (gqespwebka )
Positive
26 May 2019
ipviwwcwzd(dgieqcryak) = msxncckdfy cytqnorgmo (gqespwebka )
Phase 3
135
wmgfceeqqa(nsjzzrabwq) = blpjhgpodq bxtcirfezv (yirodbrmkk, 0.93)
Similar
01 May 2019
wmgfceeqqa(nsjzzrabwq) = virsywbgnn bxtcirfezv (yirodbrmkk, 1.10)
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Deal

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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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