更新于：2024-11-21

Filgrastim biosimilar(Emcure Pharmaceuticals Ltd.)

非格司亭生物类似药(Emcure Pharmaceuticals Ltd.)

更新于：2024-11-21

概要

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

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

靶点

CSF-3R

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

血液及淋巴系统疾病

在研适应症

中性粒细胞减少

非在研适应症-

原研机构

Emcure Pharmaceuticals Ltd.

在研机构

Emcure Pharmaceuticals Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

印度 (2013-01-01),

中性粒细胞减少

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 4190

当前序列信息引自: *****

关联

100 项与非格司亭生物类似药(Emcure Pharmaceuticals Ltd.) 相关的临床结果

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100 项与非格司亭生物类似药(Emcure Pharmaceuticals Ltd.) 相关的转化医学

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100 项与非格司亭生物类似药(Emcure Pharmaceuticals Ltd.) 相关的专利（医药）

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项与非格司亭生物类似药(Emcure Pharmaceuticals Ltd.) 相关的文献（医药）

2021-09-01·Analytical Biochemistry4区 · 生物学

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

4区 · 生物学

Article

作者: Gholizadeh-Hashjin, Aiesheh ; Lotfipour, Farzaneh ; Abedi, Nasim ; 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.

2013-01-01·Case Reports in Hematology

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

Article

作者: 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 Nanomedicine2区 · 医学

Review on lipegfilgrastim

2区 · 医学

ArticleOA

作者: 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 项与非格司亭生物类似药(Emcure Pharmaceuticals Ltd.) 相关的药物交易

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