Comparative Safety and Effectiveness of Bevacizumab Biosimilars to Originator for the Treatment of Metastatic Colorectal Cancer
Canadian Centre for Applied Research in Cancer Control, Toronto, Ontario, Canada
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Canadian Centre for Applied Research in Cancer Control, Toronto, Ontario, Canada
Now with Morse Consulting Inc., Toronto, Ontario, Canada
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Canadian Centre for Applied Research in Cancer Control, Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
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Canadian Centre for Applied Research in Cancer Control, Toronto, Ontario, Canada
ICES, Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
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Background: Ontario has publicly funded biosimilar bevacizumab for first-line metastatic colorectal cancer (mCRC) since 2019. Clinical trials demonstrate comparable efficacy and safety of bevacizumab biosimilars to originator bevacizumab. The objective of this study was to assess real-world safety and effectiveness of the implementation of bevacizumab biosimilars compared with originator bevacizumab in patients with mCRC. Methods: This was a population-based, retrospective study comparing Ontario patients starting treatment with bevacizumab biosimilars between August 12, 2019, and March 31, 2021, and starting treatment with originator bevacizumab between July 2, 2008, and August 11, 2019. Safety outcomes included death within 30 days of the last dose received, any hospitalization, direct hospitalization, and hospitalization resulting from bevacizumab-related toxicity, chemotherapy-related toxicity, and febrile neutropenia. Event rates were assessed using negative binomial and logistic regression. The effectiveness outcome was overall survival, calculated using Kaplan-Meier and Cox proportional hazards regression. A subgroup analysis compared safety and effectiveness outcomes between patients on bevacizumab biosimilar products and matched comparators. Results: We identified 8,996 patients who initiated first-line treatment of bevacizumab for mCRC. Accounting for duration of follow-up, no significant differences were observed in the rate of hospitalization between treatment groups. No differences in overall survival (log-rank P>.05) or hazard ratios (propensity score–matched hazard ratio, 1.03; 95% CI, 0.92–1.16) were observed in the crude and propensity score–matched cohorts. Subgroup analysis demonstrated similar safety and effectiveness patterns. Conclusions: The demonstrated similarity in safety and effectiveness between bevacizumab biosimilars and originator bevacizumab provides further support for the use of and confidence in biosimilar products.
Submitted November 22, 2023; final revision received June 20, 2024; accepted for publication July 1, 2024.
C. Muñoz and J.M. Beca contributed equally.
Author contributions: Concept & design: Beca, Mercer, Arias, Gavura, Chan. Data acquisition, analysis, or interpretation of data: Beca, Dvorani, Chan. Statistical analysis: Dvorani. Funding acquisition: Mercer, Chan. Administrative, technical, or material support: Dvorani, Mercer, Chan. Supervision: Beca, Chan. Drafting of manuscript: Muñoz, Mercer. Critical revision of the manuscript for important intellectual content: All authors.
Data availability statement: The dataset from this study is held securely in coded form at ICES. ICES is an independent, non-profit research institute funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care (MLTC). As a prescribed entity under Ontario’s privacy legislation, ICES is authorized to collect and use health care data for the purposes of health system analysis, evaluation and decision support. Secure access to these data is governed by policies and procedures that are approved by the Information and Privacy Commissioner of Ontario. Although legal data sharing agreements between ICES and data providers (eg, health care organizations and government) prohibit ICES from making the dataset publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS (email: das@ices.on.ca). The full dataset creation plan and underlying analytic code are available from the authors upon request, understanding that the computer programs may rely upon coding templates or macros that are unique to ICES and are therefore either inaccessible or may require modification.
Disclosures: The authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: This study was funded by the Ontario Institute for Cancer Research through grant HSR-137. This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care (MLTC).
Disclaimer: The analyses, conclusions, opinions and statements expressed herein are solely those of the authors and do not reflect those of the funding or data sources; no endorsement is intended or should be inferred.
Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7053. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.
Supplementary Materials
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