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Epoetin Alfa-BioSimilar
Epoetin alfa is a recombinant erythropoietin that stimulates red blood cell production by binding to erythropoietin receptors on bone marrow progenitor cells.
Epoetin alfa is a recombinant erythropoietin that stimulates red blood cell production by binding to erythropoietin receptors on bone marrow progenitor cells. Used for Anemia associated with chronic kidney disease, Anemia in patients with cancer receiving chemotherapy, Anemia in patients undergoing major surgery.
At a glance
| Generic name | Epoetin Alfa-BioSimilar |
|---|---|
| Also known as | EPO, epoetin, erythropoietin, erythropoiesis-stimulating agent, ESA, haematopoietin, haemopoietin |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Drug class | Erythropoiesis-stimulating agent (ESA) |
| Target | Erythropoietin receptor (EPOR) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Epoetin alfa is a biosimilar version of recombinant human erythropoietin (EPO), which mimics the natural hormone that regulates red blood cell production. It binds to EPO receptors on erythroid progenitor cells in the bone marrow, promoting their proliferation and differentiation into mature red blood cells. This increases hemoglobin levels and oxygen-carrying capacity in patients with anemia.
Approved indications
- Anemia associated with chronic kidney disease
- Anemia in patients with cancer receiving chemotherapy
- Anemia in patients undergoing major surgery
Common side effects
- Hypertension
- Headache
- Thrombotic events (DVT, PE, stroke)
- Pure red cell aplasia
- Injection site reactions
Key clinical trials
- Hydroxyurea and EPO in Sickle Cell Disease (PHASE1, PHASE2)
- Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome
- A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (PHASE2)
- Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology
- Study to Compare the Safety and Efficacy of UB-851 and Eprex® (PHASE3)
- Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study) (PHASE3)
- Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study) (PHASE4)
- Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Epoetin Alfa-BioSimilar CI brief — competitive landscape report
- Epoetin Alfa-BioSimilar updates RSS · CI watch RSS
- Hospital de Clinicas de Porto Alegre portfolio CI