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Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

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A Letter to the Editor to this article was published on 16 April 2021

A Letter to the Editor to this article was published on 16 April 2021

Abstract

Background

Since the approval and availability of the first biosimilar in 2015 in the United States (US), evidence regarding the post-marketing safety of cancer supportive care biosimilars remains limited.

Objective

The aim was to explore the adverse event (AE) reporting patterns and detect disproportionate reporting signals for cancer supportive care biosimilars in the US compared to their originator biologics.

Methods

The US Food and Drug Administration Adverse Event Reporting System database (January 1, 2004–March 31, 2020) was used to identify AE reports for filgrastim, pegfilgrastim, and epoetin alpha by type of product (originator biologics vs. biosimilars) and report characteristics. Plots of AE reports against years were used to reveal the reporting patterns. Disproportionality analyses using reporting odds ratios (RORs) were conducted to detect differences in serious and specific AEs between studied drugs and all other drugs. Breslow–Day tests were used to determine homogeneity between the originator biologic–biosimilar pair RORs for the same AE.

Results

Total numbers of AEs for all studied biosimilars increased after marketing. More AE reports were from female patients for all of the studied drugs. More AEs for originator biologics and filgrastim biosimilar were reported by health professionals, while the highest proportion of reports came from consumers for pegfilgrastim and epoetin alpha biosimilars (29% and 44.1%, respectively). Signals of disproportionate reporting in serious AEs were detected for a pegfilgrastim biosimilar (Fulphila®) compared to its originator biologic.

Conclusion

Our findings support the similarity in the signals of disproportionate reporting between cancer supportive care originator biologics and biosimilars, except for Fulphila®.

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Acknowledgements

The authors would like to thank and acknowledge Drs. Surachat Ngorsuraches and Kimberly Garza, associate professors at Auburn University Harrison School of Pharmacy, for their feedback on research proposal development. We also thank Mr. Whitt Krehling, Auburn University, for his assistance in editing the manuscript.

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Authors and Affiliations

  1. Department of Health Outcomes Research and Policy, Auburn University Harrison School of Pharmacy, Auburn, AL, USA

    Kaniz Afroz Tanni, Cong Bang Truong, Sura Almahasis & Jingjing Qian

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  1. Kaniz Afroz Tanni
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  2. Cong Bang Truong
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Corresponding author

Correspondence to Jingjing Qian.

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Funding

No financial assistance was used to conduct the study described in the article and/or used to assist with the preparation of the article.

Conflict of Interest

There are no conflicts of interest to report for all authors.

Data Availability

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.

Ethics Approval

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.

Informed Consent

Not applicable.

Author Contributions

KAT, CBT, and JQ 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: All authors. Acquisition, analysis, or interpretation of data: KAT, CBT, and JQ. Drafting of the paper: All authors. Critical revision of the paper for important intellectual content: All authors. Statistical analysis: KAT and CBT. Study supervision: JQ.

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Tanni, K.A., Truong, C.B., Almahasis, S. et al. Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database. BioDrugs 35, 239–254 (2021). https://doi.org/10.1007/s40259-020-00466-3

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