Last update 01 Nov 2024

Filgrastim biosimilar(Emcure Pharmaceuticals Ltd.)

Last update 01 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Recombinant G-CSF biosimilar (Emcure Pharmaceuticals), Recombinant filgrastim biosimilar (Emcure Pharmaceuticals), rhG-CSF biosimilar (Emcure Pharmaceuticals)

Target

CSF-3R

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Neutropenia

Inactive Indication-

Originator Organization

Emcure Pharmaceuticals Ltd.

Active Organization

Emcure Pharmaceuticals Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (01 Jan 2013),

Neutropenia

Regulation-

Gene Sequence

Sequence Code 4190

The sequence is quoted from: *****

100 Clinical Results associated with Filgrastim biosimilar(Emcure Pharmaceuticals Ltd.)

100 Translational Medicine associated with Filgrastim biosimilar(Emcure Pharmaceuticals Ltd.)

100 Patents (Medical) associated with Filgrastim biosimilar(Emcure Pharmaceuticals Ltd.)

Literatures (Medical) associated with Filgrastim biosimilar(Emcure Pharmaceuticals Ltd.)

01 Sep 2021·Analytical BiochemistryQ4 · BIOLOGY

Direct quantitative detection of host cell residual DNA in recombinant Filgrastim by qPCR

Q4 · BIOLOGY

Article

Author: Gholizadeh-Hashjin, Aiesheh ; Abedi, Nasim ; Lotfipour, Farzaneh ; Heidari, Hamid Reza

Host cell residual DNA is considered as an impurity in recombinant biopharmaceuticals. This study aimed to develop a direct qPCR method to quantify E. Coli residual DNA in recombinant Filgrastim. The specific primers were designed to amplify E. Coli's 16S-rDNA genomic region, which encodes the 16S-rRNA. The developed qPCR method showed that the designed primer has specifically amplified the target genome without any secondary reaction. The designed primer was also able to amplify the target gene as a representative of residual DNA in the drug matrix. Results show that the amount of residual DNA in Filgrastim is undetectable.

01 Jan 2013·Case Reports in Hematology

Safety of Pegfilgrastim (Neulasta) in Patients with Sickle Cell Trait/Anemia

Article

Author: Peethambaram, Prema P. ; Kasi, Pashtoon Murtaza ; Patnaik, Mrinal M.

Pegfilgrastim (Neulasta) is a recombinant filgrastim (human granulocyte colony-stimulating factor (G-CSF)) attached to a polyethylene glycol (PEG) molecule and is given as part of chemotherapy regimens that are associated with significant myelosuppression and risk for febrile neutropenia. Prescribing information available on manufacturer’s website for the drug warns us about possible severe sickle cell crises related to the medication but does not report the actual incidence or the use in patients with sickle cell trait. Caution is advised when using it in patients with sickle cell disease. Here we present a case of a Caucasian female with known sickle cell trait (SCT) with no prior complications who developed a presumed sickle cell crisis after getting Neulasta, as a part of the chemotherapy regimen used to treat her breast cancer. Based on our literature review, this appears to be the first case report of a patient with SCT developing a sickle cell crisis with the pegylated form of recombinant filgrastim. Given the dearth of literature regarding the use of G-CSF and its related pegylated forms in patients with sickle cell anemia and sickle cell trait, a discussion of potential mechanisms and review of current literature and guidelines is also presented.

International Journal of NanomedicineQ2 · MEDICINE

Review on lipegfilgrastim

Q2 · MEDICINE

ArticleOA

Author: Gasparic, Maja ; Leyman, Sophie

A polemic in response to Hoggatt et al. (Int J Nanomedicine. 2015;10:2647-2652) is given.Hoggatt et al. described lipegfilgrastim as "lipegfilgrastim has an active substance that is similar to filgrastim, with similar pharmacokinetics, receptor binding affinity, safety and efficacy as pegfilgrastim" and did not give the correct indications for either filgrastim or lipegfilgrastim.However the authors believe lipegfilgrastim would be more accurately described as "glycopegylated, long-acting form of recombinant human filgrastim" and it is to be used for reducing the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.

100 Deals associated with Filgrastim biosimilar(Emcure Pharmaceuticals Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Neutropenia	IN	Emcure Pharmaceuticals Ltd.	01 Jan 2013

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