Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis

Yang, Jichun; Yu, Shuqing; Yang, Zhirong; Yan, Yusong; Yao, Chen; Zeng, Hongmei; Ma, Fei; Shi, Yanxia; Shi, Yehui; Sun, Feng

doi:10.1007/s40259-019-00356-3

Cited by 19 publications

(18 citation statements)

References 64 publications

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“…Additionally, when compared with PEG-F, a non-significant increase in the incidence of bone pain was observed with FIL (RR 0.56, 95% CI 0.26 to 1.19). These results are consistent with results of other meta-analyses [85,96]. Another ADR observed was thrombocytopenia, which developed as an undesirable side-effect after PEG-F administration [69,74].…”

Section: Discussionsupporting

confidence: 91%

Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis

Rastogi

Kalaiselvan

Ali

et al. 2021

Biology

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Background: The aim of this review and meta-analysis was to identify, assess, meta-analyze and summarize the comparative effectiveness and safety of filgrastim in head-to-head trials with placebo/no treatment, pegfilgrastim (and biosimilar filgrastim to update advances in the field. Methods: The preferred reporting items for systematic reviews and meta-analyses PRISMA statement were applied, and a random-effect model was used. Primary endpoints were the rate and duration of grade 3 or 4 neutropenia, and an incidence rate of febrile neutropenia. Secondary endpoints were time to absolute neutrophil count ANC recovery, depth of ANC nadir (lowest ANC), neutropenia-related hospitalization and other neutropenia-related complications. For filgrastim versus biosimilar filgrastim comparison, the primary efficacy endpoint was the mean difference in duration of severe neutropenia DSN. Results: A total of 56 studies were considered that included data from 13,058 cancer patients. The risk of febrile neutropenia in filgrastim versus placebo/no treatment was not statistically different. The risk ratio for febrile neutropenia was 0.58, a 42% reduction in favor of filgrastim. The most reported adverse event with FIL was bone pain. For pegfilgrastim versus filgrastim, no statistically significant difference was noted. The risk ratio was 0.90 (95% CI 0.67 to 1.12). The overall difference in duration of severe neutropenia between filgrastim and biosimilar filgrastim was not statistically significant. The risk ratio was 1.03 (95% CI 0.93 to 1.13). Conclusions: Filgrastim was effective and safe in reducing febrile neutropenia and related complications, compared to placebo/no treatment. No notable differences were found between pegfilgrastim and filgrastim in terms of efficacy and safety. However, a similar efficacy profile was observed with FIL and its biosimilars.

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Section: Discussionsupporting

confidence: 91%

Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis

Rastogi

Kalaiselvan

Ali

et al. 2021

Biology

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“…10 A number of studies using clinical trial and real-world evidence data have demonstrated the similar efficacy, effectiveness, and safety between biosimilar and reference filgrastim. [11][12][13][14] In addition, Grewal et al and McBride et al developed theoretical frameworks and showed potential cost savings for filgrastim products in the US market. 15,16 But real-world evaluations in the uptake and cost savings of biosimilar filgrastim-sndz in nationally representative populations remain limited.…”

Section: What This Study Addsmentioning

confidence: 99%

Uptake and cost of biosimilar filgrastim among Medicare and Medicaid populations in 2015-2018

Qian

2021

JMCP

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BACKGROUND:The first biosimilar product filgrastim-sndz was approved by the FDA in 2015, but real-world evaluations of its uptake and cost in nationally representative populations are limited. OBJECTIVE:To evaluate the uptake and cost of filgrastim-sndz, relative to its originator filgrastim and alternative biologic tbofilgrastim, among Medicare and Medicaid populations. METHODS: Using the annually aggregated, product-level utilization and cost data of biologic and biosimilar filgrastim products in 2015-2018 from CMS drug spending data, total number of claims and costs for all 3 filgrastim products were identified and extracted for Medicare Part B, Part D, and Medicaid reimbursement. Annual average cost per claim and per beneficiary of individual filgrastim products were also extracted, and their annual growth rates were calculated. RESULTS: Three years after entering the US market, use of filgrastim-sndz increased to 49.1% and 46.0% of all filgrastim claims paid by Medicare Parts B and D, respectively, and to 38.7% of filgrastim Medicaid claims in 2018. Total cost for filgrastim-sndz also reached 42.8%, 41.8%, and 26.9% of all filgrastim products paid by Medicare Parts B and D and Medicaid, respectively. Significant reductions in average cost per claim for filgrastim-sndz in 2017 and 2018 were observed in Medicare Part B and Medicaid. CONCLUSIONS: Significant uptake of biosimilar filgrastim in Medicare and Medicaid programs occurred during the first 3 years of marketing. Policymakers may use the evidence to evaluate existing barriers and policies regarding biosimilar adoption.

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“…Unfortunately, although blood transfusion or erythropoietin stimulator can improve the symptoms of anemia, it does not improve the outcome of patients. [ 36 ] Recent studies have shown that perioperative blood transfusion does not improve outcomes of STS patients and is associated with all-cause mortality, cancer-related mortality, and relapse. [ 37 , 38 ] Similarly, the use of erythropoietin preparations does not improve patient survival and increases the risk of venous thrombosis in patients.…”

Section: Discussionmentioning

confidence: 99%

Prognostic value of pretreatment anemia in patients with soft tissue sarcoma

Shi

Wang

et al. 2021

Medicine

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Background: Anemia is one of the most common manifestations in patients with cancer. Recently, multiple studies have shown a positive correlation between pretreatment anemia and tumor prognosis. Yet, the relationship between pretreatment anemia and the prognosis of soft tissue sarcomas (STS) is unclear. Methods: We searched the PubMed and EMBASE databases to identify relevant studies. Eligible studies were included according to the inclusion criteria to assess the relationship between pretreatment anemia and the prognosis of patients with STS. Prognostic significance was determined by studying hazard ratios (HR) and 95% confidence intervals (CIs). Results: A total of 12 studies are included. If there is significant heterogeneity, a random-effects model is used. Pooled data indicated that pretreatment anemia is related to poor overall survival (HR = 2.13; 95%CI = 1.52–2.98), disease-specific survival (HR = 1.53; 95%CI = 1.20–1.96), and disease-free survival (HR = 1.55; 95%CI = 1.10–2.17). The results of the subgroup analysis also support this conclusion. Conclusion: Our results suggest that pretreatment anemia may be a prognostic biomarker for STS.

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Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis

Cited by 19 publications

References 64 publications

Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis

Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis

Uptake and cost of biosimilar filgrastim among Medicare and Medicaid populations in 2015-2018

Prognostic value of pretreatment anemia in patients with soft tissue sarcoma

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