Budget Impact Analysis of the Introduction of a Trastuzumab Biosimilar for HER2-Positive Breast Cancer in China

Chai, Qingqing; Wen, Haini; Lang, Yitian; Zhang, Lingyu; Song, Yan; Liu, Xiaoyan

doi:10.1007/s40261-022-01197-9

Cited by 5 publications

(1 citation statement)

References 39 publications

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“…4 On a worldwide scale, biosimilars for the treatment of cancer are typically discounted by 30% in Europe, 10% to 33% in the US, and 30% in Japan. 4 In the current circumstances, the reimbursement policy for biosimilars and their reference drugs is identical in China 84 (eTable 17 in Supplement 1). Interestingly, in 2022, trastuzumab biosimilars had a lesser price drop than the reference drug (90% of the reference drug price) compared with rituximab biosimilars (69% of the reference drug price) and bevacizumab biosimilars (74% of the reference drug price), possibly because only trastuzumab biosimilars were approved in China.…”

Section: Discussionmentioning

confidence: 99%

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

Luo,

Du,

et al. 2023

JAMA Netw Open

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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.

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Section: Discussionmentioning

confidence: 99%

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

Luo,

Du,

et al. 2023

JAMA Netw Open

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QL1701 (a proposed trastuzumab biosimilar) versus reference trastuzumab plus docetaxel as first-line therapy for HER2-positive metastatic breast cancer: a multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial

Zhang,

Cai,

Song

et al. 2024

ESMO Open

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Real-World Evidence of Biosimilar Utilisation and Pharmacoeconomics in People Living with Breast or Lung Cancer

Moir

2023

EMJ Oncol

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As the medical community continues to explore and harness the potential of biosimilars, it is imperative to accumulate robust real-world evidence (RWE) to guide informed decision-making, and enhance patient outcomes in cancer treatment. This article reviews the current understanding and utilisation of biosimilars in the treatment of breast and lung cancers by reviewing existing RWE. A literature search of PubMed, MEDLINE, and Scopus was performed to analyse observational studies pertaining to the adoption of biosimilars in people living with breast or lung cancer, with publications considered since 2019. The review summarises the current RWE relating to biosimilar use for its approved indications across breast and lung cancer. Despite the scarcity of evidence addressing the cost-effectiveness of biosimilars in breast and lung cancer treatment, biosimilars may offer a dual benefit by enhancing patient outcomes, while ensuring cost-effectiveness, thereby increasing access to oncology therapies globally. The increased access to biosimilars within community oncology practices, hospitals, and national healthcare systems, promises substantial cost savings. This review highlights the evolving landscape of biosimilar utilisation in oncology, revealing their potential as a more affordable and inclusive approach to cancer care, while also indicating areas for further research.

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Budget Impact Analysis of the Introduction of a Trastuzumab Biosimilar for HER2-Positive Breast Cancer in China

Cited by 5 publications

References 39 publications

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

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

QL1701 (a proposed trastuzumab biosimilar) versus reference trastuzumab plus docetaxel as first-line therapy for HER2-positive metastatic breast cancer: a multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial

Real-World Evidence of Biosimilar Utilisation and Pharmacoeconomics in People Living with Breast or Lung Cancer

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