A recent study in Italy found that switching between biosimilars when treating patients in oncohematology centres for non-Hodgkin lymphoma or chronic lymphocytic leukaemia does not increase the risk of adverse events. It also confirmed the clinical safety of using rituximab biosimilars.
The findings should alleviate concerns about the use of biosimilars and could lead to a broader acceptance of their use and an awareness of their potential to reduce healthcare costs.
The study authors suggest that regulators and prescribers should share guidelines to encourage their adoption.
The clinical safety and efficacy of rituximab biosimilars compared to the reference rituximab (brand name MabThera) have been well established in randomised trials, but concerns remain around switching from the reference product, and particularly between different biosimilars.
This analysis showed that only 22% of patients were given different biosimilars during treatment, and most were only treated with the biosimilars Rixathon and Truxima.
The multicentre observational study involved across 13 oncohematology units in Italy. Only patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukaemia who had not had rituximab treatment were included in the study (n=505).
A total of 3,681 rituximab infusions were administered as either the reference product or a biosimilar, and 16.8% of the patients experienced at least one adverse drug reaction (ADR). These were observed most frequently during the first infusion (44 patients, 52%) and the second infusion (17 patients, 20%) From the third to the fifteenth infusion, the incidence remained below 2%. The most frequent reactions were general disorders and administration site conditions (n=50, 8% serious).
Of the 85 ADRs, four occurred in ‘switcher’ patients, whereas 81 occurred in ‘no-switcher’ patients.
These findings support the clinical safety of rituximab biosimilars and suggest that switching between biosimilars does not increase the risk of adverse events, the authors concluded.
Reference
Urru, S et al. The Importance of Real-World Data in Evaluating the Safety of Biosimilars: A Descriptive Study of Clinical Practice in an Oncohematological Italian Population. Cancers 2024; Oct 8th: DOI: 10.3390/cancers16193419.
