Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

Abstract

ImportanceThe 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.ObjectivesTo compare characteristics of pivotal clinical trials in China and other countries for biosimilars of bevacizumab, rituximab, and trastuzumab and investigate the efficacy or effectiveness, safety, and immunogenicity outcomes of cancer biosimilars compared with reference drugs by meta-analysis.Data SourcesFor this systematic review and meta-analysis, PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for published studies from database inception to February 1, 2023, using the search topics (cancers) AND (biosimilars).Study SelectionRandomized clinical trials and cohort studies that included patients with cancer were included.Data Extraction and SynthesisTwo authors independently extracted the outcome estimates and characteristics for each study. A random-effects meta-analysis was performed to summarize the relative estimates with 95% CIs. This study was performed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline.Main Outcomes and MeasuresClinical trial characteristics were collected for biosimilars of bevacizumab, rituximab, and trastuzumab. The relative estimates of efficacy or effectiveness (objective response rate, progression-free survival, and overall survival), safety, and immunogenicity outcomes were analyzed for biosimilars vs reference drugs. The weighted average price and uptake rate were evaluated for biosimilars relative to their reference drugs between 2015 and 2022.ResultsA total of 39 RCTs (involving 18 791 patients) and 10 cohort studies (involving 1998 patients) were included. 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.Conclusions and RelevanceThis systematic review and meta-analysis indicated that cancer biosimilars provided comparable clinical benefits at lower prices compared with reference drugs. These findings suggest the potential feasibility of expediting the transition from reference drugs to biosimilars to benefit more patients with cancer.

Are Cancer Biosimilars Similar and Significant Enough to Deserve More Attention?

“…In the study by Luo et al, 5 39 randomized clinical trials (RCTs) with a total of 18 791 enrolled patients were included, with 18 RCTs focused on bevacizumab, 12 on rituximab, and 9 on trastuzumab biosimilars. In addition, 10 retrospective cohort studies with 1998 patients were also included for biosimilars of the 3 reference cancer drugs.…”

“…The study by Luo et al 5 offered valuable perspectives on the effectiveness of using biosimilars to narrow the gap between patient needs and their limited access to effective anticancer biologics and highlighted the importance of evaluating the quality consistency between biosimilars and their reference drugs. Their study suggests that designing and implementing policies and measures that promote the use of cancer biosimilars may play a positive role in reducing cancer-associated health burden in China; these policies and measures may include adjusting current payment coverage in the government's health welfare system and the drug tender purchase standards and bolstering legal regulations to support industrial development of cancer biosimilars.…”

“…doi:10.1001/jamanetworkopen.2023.37355 (Reprinted) October 12, 2023 1/Downloaded from jamanetwork.com by guest on 05/30/2024The insightful work presented by Luo et al5 offers the cancer-fighting community and the broader health care arena more evidence-based options in combating life-threatening diseases through systemically comparing the clinical benefits, prices, and uptake between cancer biosimilars and their reference drugs. While the study by Luo et al5 focused on cancer biosimilars approved inChina, other studies in the US and the European Union found similar clinical benefits of cancer biosimilars compared with reference drugs 8,9. More extensive studies to generalize the findings to benefit a broader range of entities may be warranted.…”

“…More extensive studies to generalize the findings to benefit a broader range of entities may be warranted. Also of note, the research included in the study by Luo et al5 focused on the primary end point of the included RCTs. Future studies focusing on other clinical outcomes important to assessing the overall effectiveness of cancer biosimilars should include, for example, overall survival and quality of life.…”