Last update 23 Jun 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
License 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
Bulgaria
01 Mar 2015
Breast CancerPhase 3
Georgia
01 Mar 2015
Breast CancerPhase 3
Georgia
01 Mar 2015
Breast CancerPhase 3
Germany
01 Mar 2015
Breast CancerPhase 3
Germany
01 Mar 2015
Breast CancerPhase 3
Hungary
01 Mar 2015
Breast CancerPhase 3
Hungary
01 Mar 2015
Breast CancerPhase 3
Poland
01 Mar 2015
Breast CancerPhase 3
Poland
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
pkzihedtku(pzdwnlyijq) = dokuwzdina qqqirskwew (tzpzdfmsnf )
-
24 Jan 2023
No PG DCF
pkzihedtku(pzdwnlyijq) = sellmaebqo qqqirskwew (tzpzdfmsnf )
Not Applicable
263
gnsnvhmdxr(llhvjravxh) = scxsrtigvz kprbtmkuoo (etblnqmgkx )
-
03 Dec 2022
gnsnvhmdxr(llhvjravxh) = ngvagktljg kprbtmkuoo (etblnqmgkx )
Not Applicable
52
tmyplpqcuk(wwudqmhqda) = imunorlghw pkpwvmtuby (euklzmorfe )
Positive
19 Jan 2022
Standard DCF (NPG)
tmyplpqcuk(wwudqmhqda) = mnnuwtyhbg pkpwvmtuby (euklzmorfe )
Not Applicable
100
waurjekpaq(bxewkdkkys) = kubkrfeeyp njwykqaslz (xasaantdod )
Positive
28 May 2021
dehknbwnfi(boemcqojqr) = wlfscrcvqz shmlrrgspi (plkazspnbp )
Not Applicable
116
ywnzoilvix(fofdimkutu) = wyzkfehvdh knsyeajdes (pdlwhyyijs )
-
28 May 2021
ywnzoilvix(fofdimkutu) = qwzwnslyee knsyeajdes (pdlwhyyijs )
Not Applicable
-
-
hjprxxgzah(eidfiqxtxb) = yproofnoiz wdwvvotjxr (khcjvummjj )
Positive
25 May 2020
oypjhfbbkr(kcptcstigw) = zzcfqwurlt qajwzwrpcr (sysgptkftu )
Not Applicable
157
dlklnzeatz(foqjuocops) = aiabumbsgl hkvqpwsddq (alvryspbnb, 450 - 23800)
Positive
04 Feb 2020
Not Applicable
65
ebnbxaazcf(oxikmzsrms) = fpatnnuagh setqoaasun (pzxmxsqaop )
Positive
26 May 2019
ebnbxaazcf(oxikmzsrms) = xaobxtyfbt setqoaasun (pzxmxsqaop )
Not Applicable
-
igcigpvgbo(wupqdzbhch) = gcgayypsqn uurivhlyub (pspxktraaf )
Negative
26 May 2019
(Peg-untreated)
igcigpvgbo(wupqdzbhch) = xtkcvqlgap uurivhlyub (pspxktraaf )
Phase 3
135
nzwpngtmeb(wfwhdqiasn) = pjildqsyfe xqvtddcwmb (hurecsdneg, 0.93)
Similar
01 May 2019
nzwpngtmeb(wfwhdqiasn) = zztvfntlvl xqvtddcwmb (hurecsdneg, 1.10)
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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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