In a recent publication in the journal Cancers, the authors indicated that their findings from an analysis of the EnduraVigliance Database provide evidence regarding the safety equivalence of biosimilars and support their use as viable options to originator biologics.
The objective of this study was to investigate the postmarketing pharmacovigilance data of biosimilar monoclonal antibodies utilized in oncology and compare them with respective reference/originator products.
Data for this study were obtained from the European Union’s postmarketing surveillance database EnduraVigliance, which is a public spontaneous reporting system maintained by the European Medicines Agency on behalf of the European Union that receives Individual Case Safety Reports of suspected adverse drug reactions (ADRs) within the European Economic Area.
Data were obtained from all reports related to biosimilars of three oncology biological products: bevacizumab, rituximab, and trastuzumab. The researchers used this data and then compared their safety profiles with the corresponding reference/originator products.
The results revealed that the most frequently reported ADRs for biosimilars were nonserious and consistent with the safety profiles of reference/originator products.
The authors wrote, “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.”
Based on their findings, the authors wrote, “Biological therapies are a cost-effective alternative that has revolutionized the treatment of oncologic diseases. Based on the analysis of ADR reports from EudraVigilance, there were no significant differences in the safety profiles between bevacizumab, trastuzumab, and rituximab biosimilars and their respective originators in Europe.”
Lastly, the authors indicated that these findings provide encouragement regarding the safety equivalence of biosimilars and support their utilization as feasible substitutes to originator biologics, and as with any medication, constant pharmacovigilance monitoring is vital to maintain the ongoing safety of oncology biosimilars.
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