Severe Hypersensitivity Reactions at Biosimilar versus Originator Rituximab Treatment Initiation, Switch and Over Time: A Cohort Study on the French National Health Data System.

ABSTRACT:

Background

Biosimilar 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.

Objective

The 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.

Methods

The 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 histor

SUBMITTER: Jourdain H 

PROVIDER: S-EPMC10195743 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature