Last update 20 Jun 2024

Pegfilgrastim-Bmez(Clariant Ag)

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
pegfilgrastim, Pegfilgrastim biosimilar, Pegfilgrastim biosimilar (Sandoz)
+ [6]
Target
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Originator Organization
Active 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
EU
22 Nov 2018
Febrile Neutropenia
IS
22 Nov 2018
Febrile Neutropenia
LI
22 Nov 2018
Febrile Neutropenia
NO
22 Nov 2018
Neutropenia
EU
22 Nov 2018
Neutropenia
IS
22 Nov 2018
Neutropenia
LI
22 Nov 2018
Neutropenia
NO
22 Nov 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ComplicationPhase 3
BR
01 Jun 2012
ComplicationPhase 3
IN
01 Jun 2012
ComplicationPhase 3
MX
01 Jun 2012
ComplicationPhase 3
RO
01 Jun 2012
ComplicationPhase 3
RU
01 Jun 2012
ComplicationPhase 3
UA
01 Jun 2012
Toxicity due to chemotherapyPhase 3
BR
01 Jun 2012
Toxicity due to chemotherapyPhase 3
IN
01 Jun 2012
Toxicity due to chemotherapyPhase 3
MX
01 Jun 2012
Toxicity due to chemotherapyPhase 3
RO
01 Jun 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
uirekbkhsh(mzidcilhbz) = Bone pain was similar with proposed biosimilar and reference pegfilgrastim, in studies of BC patients and HVs ftugycxlxq (qsuggycobm )
-
22 Oct 2018
Phase 3
308
(LA-EP2006)
lishquvabh(ufvsewdgoy): Mean Difference (Net) = -0.16 (95% CI, -0.40 to 0.08), P-Value = 0.05; Mean Difference (Net) = -0.16 (95% CI, -0.40 to 0.08), P-Value = 0.05
-
28 Jun 2017
(Neulasta®)
Phase 3
316
(LA-EP2006)
woodguyckz(mausurpnkg): Mean Difference (Net) = 0.07 (95% CI, -0.12 to 0.26), P-Value = 0.05; Mean Difference (Net) = 0.07 (95% CI, -0.12 to 0.26), P-Value = 0.05
-
15 Jun 2017
(Neulasta®)
Phase 3
Neutropenia | Breast Cancer
Adjuvant | Neoadjuvant
308
jpccvkpkmh(yxmobhjgch) = iqkyffypvb uzzumakdzy (vgkekarixa, 1.13)
Similar
01 Jul 2016
jpccvkpkmh(yxmobhjgch) = lqdkyxpdgg uzzumakdzy (vgkekarixa, 0.98)
Phase 3
316
cqwoqavvws(usmifbpbns): difference = 0.07 (90% CI, -0.09 to 0.23)
Similar
01 Jun 2016
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