Abstract
Background Bevacizumab is one of the most effective anticancer treatment options for patients with unresectable advanced or recurrent colorectal cancer. The high cost of the drug has been a barrier to its use, but in recent years, biosimilars with lower prices have been launched in Japan. This study compared the efficacy, safety, and cost-effectiveness of the originator and biosimilar products in Japanese patients with colorectal cancer. Methods This is a single-center, retrospective, observational cohort study including patients diagnosed with colorectal cancer who received the originator bevacizumab (Avastin®) or a biosimilar ABP 215 between January 2018 and April 2024. Enrolled colorectal cancer patients were divided into two cohorts: those who only received the originator and those who received only the biosimilar ABP 215 until the end of bevacizumab therapy. Efficacy was evaluated in terms of progression-free survival (PFS) over a two-year follow-up period. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Results A total of 159 patients were eligible for this study and divided into the originator cohort (n=121) and the biosimilar ABP 215 cohort (n=38). The Kaplan-Meier curves and a log-rank test showed no significant differences in median PFS between the originator and biosimilar ABP 215 cohorts (8.41 months [95% CI, 7.33-9.43] and 7.13 months [95% CI, 5.03-9.66], respectively, p= 0.460). The hazard ratio was 1.07 (95% CI, 0.89-1.29, p= 0.462). The incidence of any grade and grade ≥3 adverse events did not differ significantly between cohorts. Economic outcomes indicated a potential savings of approximately 800,000 Japanese yen per patient with biosimilar ABP 215 use. Conclusions Although this is a single-center, retrospective, observational study with limitations in terms of the number of cases and background factors, the use of the bevacizumab biosimilar ABP 215 product is recommended in Japan from the perspective of reducing medical costs, given the findings of no differences in efficacy and safety.