In a systematic review and meta-analysis published in the Journal of the American Medical Association Network Open, authors compared features of pivotal clinical trials in China and other countries for biosimilars of bevacizumab, rituximab, and trastuzumab and explored the efficacy or effectiveness, safety, and immunogenicity outcomes of oncology biosimilars compared with reference/originator drugs utilizing a meta-analysis.

The authors wrote, “The high cost of biologics used to treat cancer has been an increasing burden in the world. In China, the recent approval of cancer biosimilar drugs to resolve this problem is promising, but evidence of clinical benefits, price, and uptake for these drugs is still lacking.”

From the database inception through February 2023, the authors searched for published studies employing PubMed, Embase, the Cochrane Library, and

Two authors individually separated the outcome estimates and characteristics for each study, and a random-effects meta-analysis was conducted to summarize the relative estimates with 95% CIs. This study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Randomized clinical trials and cohort studies that included patients with cancer were incorporated.

With regard to primary outcomes and measures, the authors noted that clinical trial characteristics were gathered for biosimilars of bevacizumab, rituximab, and trastuzumab, and the relative estimates of efficacy or effectiveness (objective response rate, progression-free survival, and overall survival), safety, and immunogenicity outcomes were investigated for biosimilars versus their reference drugs. Between 2015 and 2022, biosimilars’ weighted average price and uptake rate were assessed relative to their reference drugs.

For this study, 39 randomized, controlled trials (RCTs) involving 18,791 patients and 10 cohort studies involving 1,998 patients were included.

The authors wrote, “The biosimilars of bevacizumab (16 RCTs; risk ratio [RR], 0.97; 95% CI, 0.93-1.01; P = .17), rituximab (12 RCTs; RR, 1.03; 95% CI, 0.98-1.08; P = .70), and trastuzumab (9 RCTs: RR, 1.04; 95% CI, 0.97-1.12; P = .29) met equivalence with reference biologics in regard to the objective response rate. The results summarized from cohort studies were consistent with those from RCTs. In 2022, cancer biosimilars were priced at 69% to 90% of the costs for the reference drugs, and their uptake reached 54% to 83% in China.”

The authors added, “The pooled analysis of 39 RCTs and 10 cohort studies revealed that bevacizumab biosimilars, rituximab biosimilars, and trastuzumab biosimilars did not differ significantly from the reference drugs with respect to efficacy, safety, and immunogenicity outcomes.”

Based on their findings, the authors concluded that their systematic review and meta-analysis indicated that oncology biosimilars provided comparable clinical benefits at lower prices compared with reference drugs. The findings suggest the possible practicability of accelerating the transition from reference drugs to biosimilars to expand access to affordable and effective therapy, especially in patients being treated for cancer, they researchers added.

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