Observational studyBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2018
Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study.
Observational study in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.
- Clinical Similarity of Biosimilars and Reference Drugs: A Comprehensive Review and New Hope for Public Health in a New Frontier.Current drug research reviews · 2025Pooled it
- Discontinuation and Switchback After Non-Medical Switching from Originator Tumor Necrosis Factor Alpha (TNF) Inhibitors to Biosimilars: A Meta-Analysis of Real-World Studies from 2012 to 2018.Advances in therapy · 2022Pooled it
- Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab.Annals of hematology · 2021Trial
- Short versus long-acting erythropoiesis-stimulating agents for anemia management in Egyptian hemodialysis patients.Qatar medical journal · 2024Article
- Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail.Chronic diseases and translational medicine · 2022Article
- Current Status of Renal Anemia Pharmacotherapy-What Can We Offer Today.Journal of clinical medicine · 2021Review
- Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- Dose equivalency and efficacy of biosimilar erythropoietin stimulating agents: Data from real clinical practice.Pharmacology research & perspectives · 2020Article
- Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study.Drug safety · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundErythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007.
aimThis study aimed to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting.
methodsA prospective study was conducted in four Italian regions between 1 October 2013 and 30 June 2015. The study population included patients aged ≥ 18 years undergoing hemodialysis and treated with epoetins as per the clinical practice of the participating centers. The two comparison cohorts included patients treated with either an originator or a biosimilar epoetin alfa. Each patient was followed up until occurrence of any safety outcome of interest (grouped into three major categories), switch to a different ESA product, transplant or peritoneal dialysis, death, or end of the study period, whichever came first.
resultsOverall, 867 subjects were included in the study (originator: N = 423; biosimilar: N = 444). Biosimilar users were older than originator users (median age of 76 vs 64 years, respectively), more frequently affected by arrhythmia (29.3 vs 22.5%), and less frequently candidates for transplantation (3.8 vs 18.2%). Cox-regression analysis showed no increase in risk of safety outcomes in biosimilar users, even after adjusting for confounding factors: 1.0 (95% confidence interval [CI] 0.7-1.3) for any outcomes; 1.1 (95% CI 0.7-1.8) for problems related to dialysis device; 0.9 (95% CI 0.6-1.5) for cardio- and cerebro-vascular conditions; 0.9 (95% CI 0.6-1.5) for infections.
conclusionThis study confirms the comparable safety profiles of originator and biosimilar epoetin alfa drugs when used in patients receiving dialysis.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.