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Erythropoietin

Generic Name
Erythropoietin
Brand Names
Procrit, Eprex, Epprex, Epoetin Alfa Hexal, Silapo, Biopoin, Abseamed, Eporatio, NeoRecormon, Epogen, Retacrit
Drug Type
Biotech
CAS Number
11096-26-7
Unique Ingredient Identifier
64FS3BFH5W

Overview

Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow . Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures . It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market . The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product . Epoetin alfa formulations can be administered intravenously or subcutaneously.

Background

Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow . Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures . It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market . The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product . Epoetin alfa formulations can be administered intravenously or subcutaneously.

Indication

用于肾功能不全合并的贫血,艾滋病本身或因治疗引起的贫血,恶性肿瘤伴发的贫血及风湿性贫血等。另外,为择期手术储存自体血而反复采血的患者,同时应用本品可预防发生贫血。

Associated Conditions

  • Anemia
  • Blood Loss During Surgery
  • Anemia caused by Zidovudine

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2017/01/02
Not Applicable
Terminated
2016/12/28
Phase 4
Withdrawn
2016/12/06
Not Applicable
Completed
2016/10/27
Phase 3
Completed
2016/08/23
Phase 4
Terminated
Hospital Son Espases
2016/07/11
Phase 3
Completed
2016/06/23
Phase 3
Completed
2016/06/16
Phase 1
Terminated
2016/05/04
Phase 2
Completed
2016/04/21
Not Applicable
UNKNOWN
Huiqing Sun

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Human Erythropoietin Injection
国药准字S20113003
生物制品
注射剂
4/15/2020
Human Erythropoietin Injection
国药准字S20133004
生物制品
注射剂
4/26/2024
Human Erythropoietin Injection
国药准字S20083023
生物制品
注射剂
9/15/2020
Human Erythropoietin Injection
国药准字S20020044
生物制品
注射剂
9/15/2020
Human Erythropoietin Injection
国药准字S20000022
生物制品
注射剂
9/15/2020
Human Erythropoietin Injection
国药准字S20133020
生物制品
注射剂
1/13/2020
Human Erythropoietin Injection
国药准字S20020045
生物制品
注射剂
9/15/2020

PPB Drug Approvals

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TGA Drug Approvals

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