{"id":"epoetin-alfa-biosimilar","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Hypertension"},{"rate":"10-20","effect":"Headache"},{"rate":"1-5","effect":"Thrombotic events (DVT, PE, stroke)"},{"rate":"<1","effect":"Pure red cell aplasia"},{"rate":"5-15","effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL1201565","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"Epoetin alfa is a recombinant erythropoietin that stimulates red blood cell production by binding to erythropoietin receptors on bone marrow progenitor cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:11:16.145Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Anemia associated with chronic kidney disease"},{"name":"Anemia in patients with cancer receiving chemotherapy"},{"name":"Anemia in patients undergoing major surgery"}]},"trialDetails":[{"nctId":"NCT05451940","phase":"PHASE1, PHASE2","title":"Hydroxyurea and EPO in Sickle Cell Disease","status":"COMPLETED","sponsor":"Julia Xu","startDate":"2023-05-25","conditions":"Anemia, Sickle Cell, Sickle Cell Disease","enrollment":17},{"nctId":"NCT06764511","phase":"","title":"Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome","status":"RECRUITING","sponsor":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","startDate":"2024-08-30","conditions":"Myelodysplastic Syndromes (MDS)","enrollment":60},{"nctId":"NCT05265325","phase":"PHASE2","title":"A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis","status":"COMPLETED","sponsor":"Kind Pharmaceuticals LLC","startDate":"2023-05-03","conditions":"Renal Anemia","enrollment":175},{"nctId":"NCT02140736","phase":"","title":"Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology","status":"COMPLETED","sponsor":"Hospira, now a wholly owned subsidiary of Pfizer","startDate":"2009-09","conditions":"Chemotherapy-induced Symptomatic Anemia, Solid Tumors, Malignant Hemopathies","enrollment":2333},{"nctId":"NCT02708914","phase":"PHASE3","title":"Study to Compare the Safety and Efficacy of UB-851 and Eprex®","status":"COMPLETED","sponsor":"UBI Pharma Inc.","startDate":"2016-03","conditions":"Renal Anemia","enrollment":269},{"nctId":"NCT02947438","phase":"PHASE3","title":"Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)","status":"COMPLETED","sponsor":"Shenyang Sunshine Pharmaceutical Co., LTD.","startDate":"2015-12","conditions":"Renal Anemia","enrollment":207},{"nctId":"NCT02522975","phase":"PHASE4","title":"Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)","status":"TERMINATED","sponsor":"Shenyang Sunshine Pharmaceutical Co., LTD.","startDate":"2015-08","conditions":"Renal Anaemia","enrollment":16},{"nctId":"NCT01626547","phase":"","title":"Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology","status":"COMPLETED","sponsor":"Hospira, now a wholly owned subsidiary of Pfizer","startDate":"2010-12","conditions":"Chemotherapy-induced Symptomatic Anaemia, Solid Tumours, Malignant Lymphomas","enrollment":291},{"nctId":"NCT01184495","phase":"PHASE3","title":"Efficacy Study of Two Formulations of Erythropoietin","status":"COMPLETED","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2008-04","conditions":"Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis","enrollment":74},{"nctId":"NCT01121237","phase":"","title":"MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5","status":"COMPLETED","sponsor":"Sandoz","startDate":"2010-02","conditions":"Chronic Kidney Disease, End-stage Renal Disease, Anaemia","enrollment":2086},{"nctId":"NCT02191150","phase":"","title":"Study of Haemodialysis Patients Switching From Aranesp to Biosimilar","status":"COMPLETED","sponsor":"Amgen","startDate":"2014-06","conditions":"Anaemia","enrollment":272},{"nctId":"NCT02341547","phase":"","title":"Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure'","status":"UNKNOWN","sponsor":"Penang Hospital, Malaysia","startDate":"2015-02","conditions":"End Stage Renal Failure, Anaemia","enrollment":44}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["EPO, epoetin, erythropoietin, erythropoiesis-stimulating agent, ESA, haematopoietin, haemopoietin"],"phase":"phase_3","status":"active","brandName":"Epoetin Alfa-BioSimilar","genericName":"Epoetin Alfa-BioSimilar","companyName":"Hospital de Clinicas de Porto Alegre","companyId":"hospital-de-clinicas-de-porto-alegre","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}