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

Author:

Nikitina Victoria1ORCID,Santi Laurini Greta1ORCID,Montanaro Nicola2ORCID,Motola Domenico1ORCID

Affiliation:

1. Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126 Bologna, Italy

2. Alma Mater Studiorum, University of Bologna, 40126 Bologna, Italy

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.

Publisher

MDPI AG

Subject

Cancer Research,Oncology

Reference52 articles.

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2. European Medicines Agency Committee for Medicinal Products for Human Use (2023, March 31). Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Available online: www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf.

3. The European Medicines Agency (2023, March 31). The European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies—Non-clinical and Clinical Issues EMA/CHMP/BMWP/403543/2010. Available online: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf.

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