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Rituximab and Trastuzumab Biosimilars Yield Acceptable Safety in Real-World Setting

October 02, 2020

Biosimilar rituximab and biosimilar trastuzumab are associated with acceptable safety profiles among patients with cancer treated in the real-world clinical setting, according to a study published in the Journal of Oncology Pharmacy Practice (2020;1078155220957079. doi:10.1177/1078155220957079).

The aim of this hospital-based prospective observational study was to assess the real-world safety profiles of rituximab and trastuzumab biosimilars in the treatment of patients with cancer in a Portuguese oncology hospital.

The study followed a cohort event monitoring approach focused on signaling suspected adverse drug reactions. Patients receiving treatment with either biosimilar rituximab or biosimilar trastuzumab were recruited over an 11-month and a 6-month period, respectively.

Researchers assessed adverse drug reaction case reports for seriousness, expectedness and causality in the Pharmacovigilance Unit of Coimbra.

Of the 94 patients undergoing treatment with rituximab or trastuzumab, 4 patients (11.4%) experienced 16 adverse drug reactions with rituximab and 1 patient (1.7%) experienced 5 adverse drug reactions with trastuzumab.

Based on the MedDRA PT coding, the most common adverse drug reaction for rituximab was chest discomfort (n = 4; 19.1%), followed by odynophagia (n = 2; 9.5%). Trastuzumab was associated with back pain, headache, pain in extremity, tachypnoea and tremor (each, n = 1; 4.8%).

“The results of this study suggest that using biosimilar rituximab and biosimilar trastuzumab to treat cancer patients in the real-world clinical setting is associated with acceptable safety profiles. No new safety problems were identified,” the study authors concluded.—Lisa Kuhns

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