Retacrit (epoetin alfa-epbx) / Stada, Norbitec, Pfizer - LARVOL DELTA

A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Sep 2026 ➔ Dec 2026

Trial initiation date • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2026 ➔ May 2027

Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Jun 2026 ➔ Sep 2026

Trial initiation date • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P2 trial • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

Effectiveness of once-weekly erythropoietin-stimulating agent in maintenance haemodialysis: a single-centre prospective cohort analysis (UKKW 2026) - "The primary aim was to assess epoetin zeta (Retacrit) effectiveness following a dosing frequency change from thrice to once weekly in a prevalent haemodialysis cohort...Nonetheless, implications of these findings extend beyond clinical effectiveness to include reduced nursing workload and pharmaceutical waste, and support for more sustainable “Green Nephrology” practices. Larger studies with longer follow-up are required to validate the cost-effectiveness and environmental impact."

Clinical • Hematological Disorders • Nephrology • Renal Disease

Audit to investigate haemoglobin levels following switch of ESA brand for haemodialysis patients. (UKKW 2026) - "Erythropoietin stimulating agents (ESAs) such as Eprex (epoetin alfa) are used to manage haemoglobin (Hb) anaemia of CKD. Overall, it is evident that the switch from Eprex to Retacrit was a success in the Trust as patient safety wasn't compromised. This audit should provide further evidence to wider Trusts to consider ESA alternatives as a cost-savings strategy and potentially improve clinical outcomes for haemodialysis on ESAs as demonstrated in this cohort."

Clinical • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

A Retrospective Study of Bloodless Administration of Cellular Therapy in a Community Medical Center in an Outpatient and Inpatient setting: Patient Characteristics and Outcomes (TCT-ASTCT-CIBMTR 2026) - "Tranexamic acid, romiplostim and Epoetin alfa-epbx support are allowed. In this retrospective cohort of patients receiving ASCT or CarT under a bloodless therapy protocol, we have seen excellent cell recovery, toxicity, and 30-day mortality outcomes in both BL-ASCT and BL-CarT recipients. There is a trend for increased hospitalization in BLCT, largely due to inpatient administration of product and monitoring. We suggest that patients who cannot receive blood products should be considered for BL-ASCT or BL-CarT."

Retrospective data • Hematological Malignancies • Infectious Disease

Reference Standard Calibration Challenges in the Case of Erythropoietin: Impact on Potency and Biosimilarity Determination. (PubMed, AAPS J) - "However, our research and development for Retacrit® (epoetin alfa-epbx), the first and only biosimilar FDA approved for all indications of Epogen®/Procrit® (epoetin alfa), showed that use of a compendial reference standard overestimated the potency of both the biosimilar and the originator product...An internal product specific reference standard and process for qualifying and maintaining future replacements are recommended. Use of specific activity as compared to percent potency or units/mL was a useful tool and can provide a means to normalize data from multiple methods and samples with differences in labelled activity from various manufacturers."

Journal

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Vadadustat (Vafseo) for anemia of chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2024 ➔ Oct 2025

Combination therapy • Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CDC25C • GNRP • PTPRC • STAT5

Daprodustat (Jesduvroq) for anemia of chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Confined Lewis Pairs: Investigation of the X-→Si20 Interaction in Halogen-Encapsulating Silafulleranes. (PubMed, Angew Chem Int Ed Engl) - "First, we evaluated the structure-determining template effect of Cl- in a systematic series of concave silapolyquinane model systems...Third, 35Cl NMR spectroscopy proved to be highly diagnostic for an experimental assessment of the Cl- →Si20 interaction as the paramagnetic shielding and, in turn, δ(35Cl) of the endohedral Cl- ion correlate inversely with Eint. Finally, we disclose the synthesis of [PPN][Cl@Si20Y20] (Y = Me, Et, Br) and provide a thorough characterization of these new silafulleranes."

Journal

Management of Epoetin Alfa-Epbx in Anemia Due to Chronic Kidney Disease (CKD): Pre- and Post-Pharmacist Evaluation Consult (ASHP 2023) - No abstract available

Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Anemia Management in Non-Dialysis CKD Patients (KIDNEY WEEK 2023) - "Nurse Practitioner clinic was utilized to provide frequent follow-up for patients on home ESA, with a specific Retacrit protocol created for them... Our study highlights the inadequate management of anemia in CKD patients, leading to avoidable healthcare utilization and compromising the chances of successful transplantation. Improved anemia management is urgently needed to address these concerns and optimize patient outcomes."

Clinical • Anemia • Hematological Disorders • Nephrology • Transplantation

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2023 ➔ Sep 2024

Combination therapy • Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

The Painful Problem of Biosimilars in the Clinic (Cancer Network) - "Co-editor-in-Chief Howard S. Hochster, MD, discusses persistent obstacles to the effective use of biosimilars in clinical practice."

Media quote

Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study. (PubMed, Clin Nephrol) - "The PASCO II study (post-authorization safety cohort observation of Retacrit and Silapo (epoetin-ζ) administered subcutaneously for the treatment of renal anemia) followed 6,346 patients (4,501 Retacrit (group R); 1,845 Silapo (group S)) for up to 3 years of subcutaneous treatment with the biosimilar epoetin-ζ. The exposure-adjusted incident rate of PRCA was 0.84 per 10,000 patient-years. This real-world study showed that among patients with renal anemia receiving subcutaneous administration of the biosimilar product epoetin-ζ, the incidence rate of PRCA was substantially below the risk observed in 2002 for Eprex and that there was no immunogenicity concern or other new safety concern."

Journal • Anemia • Cardiovascular • Hematological Disorders

Pharmacist-driven epoetin alfa-epbx dosing for hospitalized patients. (PubMed, Am J Health Syst Pharm) - "Pharmacist-driven ESA dosing was associated with significant decreases in ESA average acquisition cost and average total dose per patient."

Journal • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

CLINICAL OUTCOMES AND HEALTHCARE RESOURCE UTILIZATION (HCRU) IN PATIENTS WITH LR-MDS REINITIATING ESAS FOLLOWING PREVIOUS ESA TREATMENT (EHA 2022) - "The most used ESA was darbepoetin alfa (60%), followed by epoetin alfa (38%) and epoetin alfa-epbx (2%). In these patients, poor clinical outcomes and frequent health system visits were observed. This study highlights the need to consider alternative treatment options for patients with LR-MDS."

Clinical • Clinical data • HEOR • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Obesity • Oncology

Clinical outcomes and healthcare resource utilization (HCRU) in patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) reinitiating erythropoiesis-stimulating agents (ESAs) following previous ESA treatment. (ASCO 2022) - "The most used ESA was darbepoetin alfa (60%), followed by epoetin alfa (38%) and epoetin alfa-epbx (2%). In this real-world study of community practice in the USA, reinitiation of ESA treatment after prior discontinuation in LR-MDS was prevalent. In these pts, poor clinical outcomes and frequent health system visits were observed. This study highlights the need to consider alternative treatment options for pts with LR-MDS."

Clinical • Clinical data • HEOR • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Obesity • Oncology

Retacrit®, Biosimilar of Epoetin alfa, in Chemotherapy-Induced Anemia in Routine Practice: Impact of Iron Supplementation. (PubMed, Oncology) - "Epoetin alpha biosimilar was effective and well tolerated for treating chemotherapy-induced anemia. Patients in subgroup with iron supplementation had lower TSAT at inclusion compared to subgroup without supplementation. Comparable mean Hb levels were achieved in both subgroups. The rate of patients with iron supplementation through the intravenous route was however insufficient."

Journal • Anemia • Cardiovascular • Chemotherapy-Induced Anemia • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • Solid Tumor

Assessing a Pharmacist's Impact on Initial Epoetin Alfa-epbx Dosing (ASHP 2021) - No abstract available

Variation in health plan coverage of ESAs for anemia due to chronic kidney disease. (PubMed, J Manag Care Spec Pharm) - "The following drugs were indicated for anemia due to CKD: darbepoetin alfa, methoxy polyethylene glycol-epoetin beta, epoetin alfa (available as two brands), and epoetin alfa-epbx. Margaretos, Panzer, and Chambers are employed by Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health. Lai was with Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health at the time of this study."

HEOR • Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS (Streetinsider.com) - "Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S."

Sales • Anemia • Immunology • Oncology