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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/17 | Phase 3 | Recruiting | |||
2025/05/21 | N/A | Not yet recruiting | |||
2025/04/09 | Phase 1 | Not yet recruiting | |||
2025/03/03 | Phase 2 | Not yet recruiting | |||
2024/12/06 | Phase 3 | Completed | |||
2024/09/10 | Early Phase 1 | Not yet recruiting | |||
2024/08/07 | Phase 2 | Recruiting | Federal University of São Paulo | ||
2024/07/22 | Phase 4 | Recruiting | |||
2023/12/21 | Phase 4 | Completed | |||
2023/11/18 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Physicians Total Care, Inc. | 54868-2523 | INTRAVENOUS, SUBCUTANEOUS | 10000 [iU] in 1 mL | 1/17/2013 | |
Janssen Products, LP | 59676-304 | INTRAVENOUS, SUBCUTANEOUS | 4000 [iU] in 1 mL | 11/1/2023 | |
Janssen Products, LP | 59676-303 | INTRAVENOUS, SUBCUTANEOUS | 3000 [iU] in 1 mL | 11/1/2023 | |
Janssen Products, LP | 59676-312 | INTRAVENOUS, SUBCUTANEOUS | 10000 [iU] in 1 mL | 11/1/2023 | |
Physicians Total Care, Inc. | 54868-5802 | INTRAVENOUS, SUBCUTANEOUS | 40000 [iU] in 1 mL | 1/17/2013 | |
Janssen Products, LP | 59676-340 | INTRAVENOUS, SUBCUTANEOUS | 40000 [iU] in 1 mL | 11/1/2023 | |
Janssen Products, LP | 59676-320 | INTRAVENOUS, SUBCUTANEOUS | 20000 [iU] in 1 mL | 11/1/2023 | |
Janssen Products, LP | 59676-310 | INTRAVENOUS, SUBCUTANEOUS | 10000 [iU] in 1 mL | 11/1/2023 | |
Physicians Total Care, Inc. | 54868-5673 | INTRAVENOUS, SUBCUTANEOUS | 20000 [iU] in 1 mL | 1/17/2013 | |
Janssen Products, LP | 59676-302 | INTRAVENOUS, SUBCUTANEOUS | 2000 [iU] in 1 mL | 11/1/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 12/18/2007 | ||
Authorised | 12/18/2007 | ||
Authorised | 12/18/2007 | ||
Authorised | 10/23/2009 | ||
Authorised | 7/16/1997 | ||
Authorised | 10/29/2009 | ||
Authorised | 10/29/2009 | ||
Authorised | 7/16/1997 | ||
Authorised | 12/18/2007 | ||
Authorised | 10/23/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
EPREX 6000 PREFILLED SYRINGE 6000 iu/0.6 ml | SIN11508P | INJECTION | 6000 iu/0.6 ml | 5/4/2001 | |
EPREX 10000 PREFILLED SYRINGES 10000 iu/ml | SIN08486P | INJECTION | 10000 iu/ml | 12/21/1995 | |
RECORMON PRE-FILLED SYRINGE 2000 iu/0.3 ml | SIN11418P | INJECTION | 2000 iu/0.3 ml | 11/1/2000 | |
EPREX 4000 PREFILLED SYRINGE 4000 iu/0.4 ml | SIN08489P | INJECTION | 4000 iu/0.4 ml | 12/21/1995 | |
EPREX 2000 PREFILLED SYRINGES 2000 iu/0.5 ml | SIN08488P | INJECTION | 2000 iu/0.5 ml | 12/21/1995 | |
EPREX 40000 PREFILLED SYRINGE 40,000 iu/ml | SIN11726P | INJECTION | 40000 iu/ml | 11/19/2001 | |
RECORMON PRE-FILLED SYRINGE 4000 iu/0.3 ml | SIN11501P | INJECTION | 4000 iu/0.3 ml | 5/3/2001 | |
Recormon Pre-filled Syringe 30,000 iu/0.6 ml | SIN13041P | INJECTION, SOLUTION | 30,000 iu/0.6 ml | 12/29/2004 | |
RECORMON PRE-FILLED SYRINGE 10000 iu/0.6 ml | SIN11423P | INJECTION | 10000 iu/0.6 ml | 11/1/2000 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Human Erythropoietin for Injection | 国药准字S19991023 | 生物制品 | 冻干粉针剂 | 8/5/2020 | |
Human Erythropoietin for Injection | 国药准字S19980080 | 生物制品 | 冻干粉针剂 | 5/12/2020 | |
Human Erythropoietin for Injection | 国药准字S19991024 | 生物制品 | 冻干粉针剂 | 5/12/2020 | |
Human Erythropoietin for Injection | 国药准字S20217021 | 生物制品 | 冻干粉针剂 | 8/30/2021 | |
Human Erythropoietin for Injection | 国药准字S19991025 | 生物制品 | 冻干粉针剂 | 7/2/2020 | |
Human Erythropoietin Injection | 国药准字S20113005 | 生物制品 | 注射液 | 7/13/2020 | |
Human Erythropoietin Injection | 国药准字S20230053 | 生物制品 | 注射剂 | 9/28/2023 | |
Human Erythropoietin Injection | 国药准字S20010018 | 生物制品 | 注射剂 | 4/26/2024 | |
Human Erythropoietin Injection | 国药准字S20000027 | 生物制品 | 注射剂 | 4/30/2020 | |
Human Erythropoietin Injection | 国药准字S19980074 | 生物制品 | 注射剂 | 7/13/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
RECORMON P/FILLED SYRINGE 5000IU/0.3ML | N/A | N/A | N/A | 12/11/2000 | |
RECORMON P/FILLED SYRINGE 4000IU/0.3ML | N/A | N/A | N/A | 1/11/2002 | |
RECORMON P/FILLED SYRINGE 2000IU/0.3ML | N/A | N/A | N/A | 12/11/2000 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
NEORECORMON epoetin beta (rch) 5000 IU/0.3 mL injection syringe | 104265 | Medicine | A | 1/9/2006 | |
NEORECORMON epoetin beta (rch) 6000 IU/0.3 mL injection syringe | 104266 | Medicine | A | 1/9/2006 | |
NEORECORMON epoetin beta (rch) 4000 IU/0.3 mL injection syringe | 104264 | Medicine | A | 1/9/2006 | |
NEORECORMON epoetin beta (rch) 2000 IU/0.3 mL injection syringe | 104262 | Medicine | A | 1/9/2006 | |
NEORECORMON epoetin beta (rch) 3000 IU/0.3 mL injection syringe | 104263 | Medicine | A | 1/9/2006 | |
NEORECORMON epoetin beta (rch) 10 000 IU/0.6 mL injection syringe | 104267 | Medicine | A | 1/9/2006 |