Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies

Harbeck, Nadia; Gascón, Pere; Krendyukov, Andriy; Hoebel, Nadja; Gattu, Sreekanth; Blackwell, Kimberly

doi:10.1634/theoncologist.2017-0348

Cited by 11 publications

(5 citation statements)

References 36 publications

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“…The safety profile for the reference and switched groups in this study was in line with the known safety profile for the reference, with musculoskeletal/connective tissue disorders the most frequently reported AEs associated with filgrastim. A pooled analysis of the two pivotal registration trials with EP2006 showed similar efficacy and safety results [10] to findings of studies carried out for the reference product.…”

Section: Discussionmentioning

confidence: 51%

Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

et al. 2018

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Section: Discussionmentioning

confidence: 51%

Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

et al. 2018

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“…18 A recently published combined analysis of this and another phase III trial on the safety of filgrastim-sndz in patients with breast cancer concluded that filgrastim-sndz has a safety profile consistent with previous studies of reference filgrastim. 22 Several retrospective studies also report similar efficacy between filgrastim-sndz and filgrastim for prophylaxis of chemotherapy-induced neutropenia. [23][24][25][26] Based on these data, filgrastim-sndz is included in the NCCN Guidelines as an appropriate substitute for filgrastim.…”

Section: Biosimilarsmentioning

confidence: 84%

NCCN Guidelines Insights: Hematopoietic Growth Factors, Version 1.2020

Becker

Griffiths²,

Alwan

et al. 2020

Journal of the National Comprehensive Cancer Network

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Management of febrile neutropenia (FN) is an integral part of supportive care for patients undergoing cancer treatment. The NCCN Guidelines for Hematopoietic Growth Factors provide suggestions for appropriate evaluation, risk determination, prophylaxis, and management of FN. These NCCN Guidelines are intended to guide clinicians in the appropriate use of growth factors for select patients undergoing treatment of nonmyeloid malignancies. These NCCN Guidelines Insights highlight important updates to the NCCN Guidelines regarding the incorporation of newly FDA-approved granulocyte-colony stimulating factor biosimilars for the prevention and treatment of FN.

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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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Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies

Cited by 11 publications

References 36 publications

Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

NCCN Guidelines Insights: Hematopoietic Growth Factors, Version 1.2020

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

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