Objective To systematically evaluate the efficacy and safety of pertuzumab biosimilars versus the original drug in patients with HER2-positive breast cancer.

Methods Databases including PubMed, Embase, Web of Science, Cochrane Library, CNKI, WanFang Data and Clinical Trials were electronically searched to collect randomized controlled trials comparing pertuzumab biosimilars with the original drugs. The retrieval time was from the establishment of each database to November 2025. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed using RevMan 5.4 software.

Results A Meta-analysis incorporating 4 Phase Ⅲ clinical trials involving 1,241 patients with HER2-positive breast cancer was conducted. The results of the Meta-analysis demonstrated that, across the 4 Phase Ⅲ trials, there were no statistically significant differences between the two groups of patients with HER2-positive breast cancer in terms of total pathologic complete response rate [RR=0.94, 95% CI (0.84, 1.05), P > 0.05], objective response rate [RR=1.00, 95% CI (0.95,1.05), P > 0.05], incidence of grade ≥3 adverse events [RR=1.09, 95% CI (0.94, 1.26), P > 0.05], and incidence of treatment-emergent adverse events [RR=1.00, 95% CI (0.95, 1.05), P > 0.05]. Furthermore, no statistically significant differences were observed in the incidence rates of other adverse events between the two groups (P > 0.05).

Conclusion Pertuzumab biosimilars exhibit clinical similarity to the original drug in terms of efficacy and safety, and can serve as an alternative to the original drug in the treatment of HER2-positive breast cancer.

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