Comparative Safety Profiles of Oncology Biosimilars vs. Originators in Europe: An Analysis of the EudraVigilance Database

SIMPLE SUMMARY: Nowadays, biosimilar drugs are numerous and widely used in many clinical fields, including oncology. However, skepticism remains towards these products among doctors and patients, particularly regarding their safety profile compared to the reference products. This prompted this comparative pharmacovigilance study using real-world clinical data. Consistent with the expected similarity in safety, our results reaffirm that biosimilars are comparable to the reference products in the real-world setting. This should further reassure and encourage their even greater use which, on the one hand, allows for all patients to be treated with the best available treatments and, on the other, frees up healthcare resources for innovative and more expensive drugs. ABSTRACT: In the last decades, the clinical management of oncology patients has been transformed by the introduction of biologics. The high costs associated with the development and production of biologics limit patient access to these therapies. The expiration of exclusive patents for biologics has led to the development and market introduction of biosimilars, offering the reduction of costs for cancer treatments. Biosimilars are highly similar to the reference products in terms of structure, biological activity, efficacy, safety, and immunogenicity. Therefore, the monitoring of biosimilars’ safety in real-world clinical practice though pharmacovigilance is essential. This study aimed to analyze the post-marketing pharmacovigilance data of biosimilar monoclonal antibodies used in oncology and compare them with respective reference products. Data of a 2-year period (1 January 2021–31 December 2022) were retrieved from EudraVigilance, and descriptive and comparative analysis were performed using the Reporting Odds Ratio to evaluate the distribution of medicine-reaction pairs related to biosimilars of three antitumor biological products and their corresponding reference products: bevacizumab, rituximab, and trastuzumab. The results showed that most frequently reported ADRs for biosimilars were non-serious and consistent with the safety profiles of reference products. These findings provide reassurance regarding safety equivalence of biosimilars and support their use as valid alternatives to originator biologics.