Adverse event reporting of marketed biosimilar and biological monoclonal antibody cancer treatments in the United States

ABSTRACT

Background

By 8 September 2022, 10 biological monoclonal antibody (mAb) biosimilar products for cancer treatment had been approved and marketed in the United States (US). This study examined adverse event (AE) reporting patterns and disproportionate reporting signals for mAb biosimilars in the US compared to their originator biologics.

Research design and methods

The US Food and Drug Adverse Event Reporting System database was used to identify AE reports for biological rituximab, bevacizumab, trastuzumab, and their marketed biosimilars. Proportions of patient age, sex and type of reporters of AEs were described for these reports. Reporting odds ratios (RORs) with 95% confidence intervals were calculated to compare reporting disproportionality in serious, death, and specific AEs between mAb biologics/biosimilars (index) and all other drugs. Breslow-Day statistic was used to determine homogeneity in RORs between each mAb biologic–biosimilar pair at p < 0.05.

Results

We observed no risk signals of serious or death AE reporting for all three mAb biosimilars. A signal of disproportionate reporting of death was detected between biological and biosimilar bevacizumab (p < 0.05).

Conclusions

Our findings support the similarity in signals of disproportionate AE reporting between mAb originator biologics and biosimilars, except for death between biological and biosimilar bevacizumab.

KEYWORDS:

• Biological monoclonal antibody
• biosimilars
• bevacizumab
• trastuzumab
• rituximab
• adverse events

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Data availability statement

The US FDA FAERS data supporting the results reported in the article can be accessed and downloaded from https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

The study was granted exemption by the Auburn University Institutional Review Board, and the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Author contributions

X Xue and J Qian had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis; Study concept and design: X Xue and J Qian; Acquisition, analysis, or interpretation of data: X Xue, CB Truong and J Qian; Drafting of the paper: X Xue and J Qian; Critical revision of the paper for important intellectual content: X Xue, CB Truong and J Qian; Statistical analysis: X Xue and CB Truong; Study supervision: J Qian.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2023.2189007

Additional information

Funding

This paper was not funded.