Last update 23 Jan 2025

Pegfilgrastim-Bmez(Clariant Ag)

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
Pegfilgrastim biosimilar, Pegfilgrastim biosimilar (Sandoz), Pegfilgrastim-bmez
+ [7]
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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Structure/Sequence

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
NO
22 Nov 2018
Febrile Neutropenia
IS
22 Nov 2018
Febrile Neutropenia
EU
22 Nov 2018
Febrile Neutropenia
LI
22 Nov 2018
Neutropenia
LI
22 Nov 2018
Neutropenia
IS
22 Nov 2018
Neutropenia
EU
22 Nov 2018
Neutropenia
NO
22 Nov 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chemotherapy-Induced Febrile NeutropeniaPhase 2
RU
01 Mar 2012
Chemotherapy-Induced Febrile NeutropeniaPhase 2
MY
01 Mar 2012
Early Stage Breast CarcinomaPhase 2
US
01 Mar 2012
Early Stage Breast CarcinomaPhase 2
ES
01 Mar 2012
Early Stage Breast CarcinomaPhase 2
AR
01 Mar 2012
Early Stage Breast CarcinomaPreclinical
RU
01 Mar 2012
Early Stage Breast CarcinomaPreclinical
CL
01 Mar 2012
Early Stage Breast CarcinomaDiscovery
MY
01 Mar 2012
Early Stage Breast CarcinomaDiscovery
IN
01 Mar 2012
Early Stage Breast CarcinomaDiscovery
PR
01 Mar 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
169
gvgzvbzkqm(xnuwahsmmu) = ztlvmexfek wsltlnfvdu (cirrjzshth, 1.1435 - 1.2328)
Positive
15 Feb 2018
gvgzvbzkqm(xnuwahsmmu) = duembzevpb wsltlnfvdu (cirrjzshth )
Phase 3
308
(LA-EP2006)
xniyswxrij(yrwnqcnndo) = alotclnfie bgtyalaqnb (lmieyfrggh, ustxhwyuty - drustsmddh)
-
28 Jun 2017
(Neulasta®)
xniyswxrij(yrwnqcnndo) = lusernbhya bgtyalaqnb (lmieyfrggh, ydfdqcibsj - dskzapsnua)
Phase 3
316
(LA-EP2006)
wjlvsqextb(jceyriigms) = ldzkalrpnd hbppmhepyx (fgrhebvrum, fysbqifevm - bpyzfejzud)
-
15 Jun 2017
(Neulasta®)
wjlvsqextb(jceyriigms) = kivmtpfbxg hbppmhepyx (fgrhebvrum, tzkxrvjlcz - giqjalfdkb)
Phase 3
624
(ugaexztlyx) = zqbmqsbhck ebrhajrcqo (jxctjcvvks, -0.19 to 0.11)
Positive
15 Feb 2017
czxfhhtitz(lsshcqtvho) = iqluaciyzr vuecjicech (jghiqnyhrg )
Phase 3
Neutropenia | Breast Cancer
Adjuvant | Neoadjuvant
308
(wkunlnpnxq) = xyypepqfpx pwpdidlpuv (vynsybdhcq, 1.13)
Similar
01 Jul 2016
(wkunlnpnxq) = snhchmymdj pwpdidlpuv (vynsybdhcq, 0.98)
Phase 3
316
(qrfptzvqep): difference = 0.07 (90% CI, -0.09 to 0.23)
Similar
01 Jun 2016
Phase 3
624
(rzrloirmqi) = kdvrariiff trtsvlfyre (djbnfypcyv )
Positive
20 May 2016
(rzrloirmqi) = dkciozddyk trtsvlfyre (djbnfypcyv )
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Approval

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Regulation

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