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Epoetin biosimilar
Epoetin biosimilar is a Erythropoiesis-stimulating agent Small molecule drug developed by Hospira, now a wholly owned subsidiary of Pfizer. It is currently in Phase 2 development for Anemia associated with chronic kidney disease, Anemia associated with chemotherapy.
Stimulates erythropoiesis by binding to the erythropoietin receptor
Stimulates erythropoiesis by binding to the erythropoietin receptor Used for Anemia associated with chronic kidney disease, Anemia associated with chemotherapy.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies. -
Big-pharma sponsor
+3.0pp
Hospira, now a wholly owned subsidiary of Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Epoetin biosimilar |
|---|---|
| Sponsor | Hospira, now a wholly owned subsidiary of Pfizer |
| Drug class | Erythropoiesis-stimulating agent |
| Target | Erythropoietin receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Epoetin biosimilars mimic the action of endogenous erythropoietin, stimulating the production of red blood cells.
Approved indications
- Anemia associated with chronic kidney disease
- Anemia associated with chemotherapy
Common side effects
- Headache
- Fatigue
- Nausea
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 biosimilar CI brief — competitive landscape report
- Epoetin biosimilar updates RSS · CI watch RSS
- Hospira, now a wholly owned subsidiary of Pfizer portfolio CI
Frequently asked questions about Epoetin biosimilar
What is Epoetin biosimilar?
How does Epoetin biosimilar work?
What is Epoetin biosimilar used for?
Who makes Epoetin biosimilar?
What drug class is Epoetin biosimilar in?
What development phase is Epoetin biosimilar in?
What are the side effects of Epoetin biosimilar?
What does Epoetin biosimilar target?
Related
- Drug class: All Erythropoiesis-stimulating agent drugs
- Target: All drugs targeting Erythropoietin receptor
- Manufacturer: Hospira, now a wholly owned subsidiary of Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Anemia associated with chronic kidney disease
- Indication: Drugs for Anemia associated with chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing