ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2023
Severe Hypersensitivity Reactions at Biosimilar versus Originator Rituximab Treatment Initiation, Switch and Over Time: A Cohort Study on the French National Health Data System.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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
5 citing papers in PubMed, 6 citations in OpenAlex.
- Skin Testing for the Detection of Rituximab Hypersensitivity in a Pediatric Case of Pemphigus Vulgaris.International journal of dermatology · 2026Article
- Clinical phenotypes, endotypes, and biomarker profiles of immediate rituximab hypersensitivity reactions: a prospective pharmacovigilance study.Frontiers in allergy · 2026Article
- Effectiveness and safety of biosimilars in pediatric inflammatory bowel diseases: an observational longitudinal study on the French National Health Data System.World journal of pediatrics : WJP · 2025Observational
- High-Dose Cyproterone Acetate and Intracranial Meningioma: Impact of the Risk Minimisation Measures Implemented in France in 2018-2019.Pharmacoepidemiology and drug safety · 2025Article
- Observational
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBiosimilar products of rituximab came to market in 2017. French pharmacovigilance centers have highlighted an excess of case reports of severe hypersensitivity reactions related to their use compared with the originator product.
objectiveThe aim of this study was to assess the real-world association between biosimilar versus originator rituximab injections and hypersensitivity reactions, among initiators and switchers, at first injection and over time.
methodsThe French National Health Data System was used to identify all rituximab users between 2017 and 2021. A first cohort consisted of patients who initiated rituximab (originator or biosimilar), while a second cohort consisted of originator-to-biosimilar switchers, matched on age, sex, deliveries history, and pathology, with one or two patients still receiving the originator product. The event of interest was defined as a hospitalization for anaphylactic shock or serum sickness following a rituximab injection.
resultsA total of 91,894 patients were included in the initiation cohort-17,605 (19%) with the originator product and 74,289 (81%) with a biosimilar. At initiation, 86/17,605 (0.49%) and 339/74,289 (0.46%) events occurred in the originator and biosimilar groups, respectively. The adjusted odds ratio of biosimilar exposure associated with the event was 1.04 (95% confidence interval [CI] 0.80-1.34), and the adjusted hazard ratio for biosimilar versus originator exposure was 1.15 (95% CI 0.93-1.42), showing no increased risk of event with biosimilar use at first injection, and over time. 17,123 switchers were matched to 24,659 non-switchers. No association was found between switch to biosimilars and occurrence of the event.
conclusionOur study does not support any association between exposure to rituximab biosimilars versus originator and hospitalization for a hypersensitivity reaction, either at initiation, at switch, or over time.
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