Last update 02 Apr 2025

Pegfilgrastim(CuraTeQ)

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
Pegfilgrastim Biosimilar (Curateq Biologics Pvt Ltd.), BP 14, BP-14
+ [2]
Target
CSF-3R
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Therapeutic Areas
Hemic and Lymphatic Diseases
Active Indication
Chemotherapy-Induced Febrile Neutropenia
Inactive Indication-
Originator Organization
Curateq Biologics Pvt Ltd.
Active Organization
Curateq Biologics Pvt Ltd.
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
Regulation-
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Structure/Sequence

Related

2
Clinical Trials associated with Pegfilgrastim(CuraTeQ)
CTRI/2023/06/054223
/ CompletedNot Applicable
Single dose study to compare pharmacokinetic, pharmacodynamic,immunogenicity & safety of BP14 (Pegfilgrastim) 6 mg/0.6 mL solutionfor Injection and ‘Neulasta’ (Pegfilgrastim) 6 mg/0.6 mL solution forInjection in healthy adult male subjects - NA
ACTRN12620000657921
/ CompletedPhase 1
A Randomized, Single-Dose, Double-Blind, Two-Sequence, Two-Period Crossover Study to compare Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of BP14 (Pegfilgrastim) with EU-approved Neulasta® in Healthy Male Adult Subjects.
100 Clinical Results associated with Pegfilgrastim(CuraTeQ)
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100 Translational Medicine associated with Pegfilgrastim(CuraTeQ)
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100 Patents (Medical) associated with Pegfilgrastim(CuraTeQ)
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100 Deals associated with Pegfilgrastim(CuraTeQ)
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Chemotherapy-Induced Febrile NeutropeniaNDA/BLA
European Union
Curateq Biologics Pvt Ltd.
30 Jan 2025
NeutropeniaNDA/BLA
Canada
Curateq Biologics Pvt Ltd.
01 Jun 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
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Deal

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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.
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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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