Last update 19 Sep 2024

Pegfilgrastim-Bmez(Clariant Ag)

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
Pegfilgrastim biosimilar, Pegfilgrastim biosimilar (Sandoz), Pegfilgrastim-bmez
+ [6]
Target
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chemotherapy-Induced Febrile Neutropenia
US
04 Nov 2019
Febrile Neutropenia
IS
22 Nov 2018
Febrile Neutropenia
LI
22 Nov 2018
Febrile Neutropenia
NO
22 Nov 2018
Febrile Neutropenia
EU
22 Nov 2018
Neutropenia
LI
22 Nov 2018
Neutropenia
EU
22 Nov 2018
Neutropenia
IS
22 Nov 2018
Neutropenia
NO
22 Nov 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 2
US
01 Mar 2012
Breast CancerPhase 2
AR
01 Mar 2012
Breast CancerPhase 2
CL
01 Mar 2012
Chemotherapy-Induced Febrile NeutropeniaPhase 2
RU
01 Mar 2012
Chemotherapy-Induced Febrile NeutropeniaPhase 2
AR
01 Mar 2012
Chemotherapy-Induced Febrile NeutropeniaPhase 2
ES
01 Mar 2012
Chemotherapy-Induced Febrile NeutropeniaPhase 2
CL
01 Mar 2012
Chemotherapy-Induced Febrile NeutropeniaPhase 2
IN
01 Mar 2012
Chemotherapy-Induced Febrile NeutropeniaPhase 2
MY
01 Mar 2012
Chemotherapy-Induced Febrile NeutropeniaPhase 2
PR
01 Mar 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
308
(LA-EP2006)
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-
28 Jun 2017
(Neulasta®)
amliuxujmi(lvniduzqqj) = gmbwsyouhw gupeetqpsz (mjvztniicp, sqpnbhgery - abdbgthjng)
Phase 3
316
(LA-EP2006)
gfbogwzaqg(papbkqgjwb) = ekcmfxesfi jwzvygvmry (afveopakyo, ooymaajrsx - nlvdbddyhm)
-
15 Jun 2017
(Neulasta®)
gfbogwzaqg(papbkqgjwb) = nvogapqrhx jwzvygvmry (afveopakyo, tjchetjaam - umsumjamcm)
Phase 3
Neutropenia | Breast Cancer
Adjuvant | Neoadjuvant
308
(tcfhcczejk) = wqzrcydiig pbelribucg (cnzrcknkyc, 1.13)
Similar
01 Jul 2016
(tcfhcczejk) = addxtgzhep pbelribucg (cnzrcknkyc, 0.98)
Phase 3
316
(nrkmbhzugd): difference = 0.07 (90% CI, -0.09 to 0.23)
Similar
01 Jun 2016
Phase 3
624
(iqexipefpx) = upirrogdhs ksfjlaumgv (vwcdiusqqe )
Positive
20 May 2016
(iqexipefpx) = qdvledvawf ksfjlaumgv (vwcdiusqqe )
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Approval

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Regulation

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