Efficacy and Safety of Nivestim Versus Neupogen for Mobilization of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation

Chew, Cindy; Ng, Hong Yen

doi:10.1038/s41598-019-56477-w

Cited by 3 publications

(1 citation statement)

References 13 publications

(17 reference statements)

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“…Filgrastim, commercially known as Neupogen, is a recombinant human G-CSF that is extensively used for PBSC mobilization in healthy donors worldwide. 3,4 It induces myeloid hyperplasia and releases CD34 + cells in circulation through proteolysis of adhesion molecules. 5 Biosimilar products are produced to reduce costs and make new, more affordable products for patients.…”

Section: Introductionmentioning

confidence: 99%

Comparison of biosimilar filgrastim and originator filgrastim for peripheral blood stem cell mobilization for allogeneic hematopoietic stem cell transplantation

Shahzad,

Amin,

Bellman

et al. 2024

Transfusion

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BackgroundNivestym, a biosimilar granulocyte colony‐stimulating factor (G‐CSF) to the originator filgrastim (Neupogen), is now being used for the mobilization of peripheral blood stem cells (PBSC) in allogeneic hematopoietic stem cell transplantation (allo‐HSCT). We aim to compare the efficacy of Nivestym and Neupogen for PBSC mobilization in healthy allogeneic donors.MethodsWe conducted a retrospective single‐center study including 541 adult allo‐HSCT donors receiving Nivestym (January 2013–July 2020), or Neupogen (July 2020–June 2023) for donor PBSC mobilization. Bivariate analysis was conducted using SPSS version 28. Statistical significance was determined at a p‐value <.05.ResultsOur study included 541 allo‐HSCT donors who received Neupogen (n = 345, 64%) or Nivestym (n = 196, 36%) for PBSC mobilization. The median age was 47 years (range 17–76). The median donor weight was 86 kg (95% confidence interval [CI]: 87–91). Donors receiving Neupogen had similar pre‐G‐CSF white blood cell count, CD34+ percentages, and circulating CD34+ count compared with donors receiving Nivestym. The Neupogen group had similar median PBSC product total neutrophil count, CD34+ percentage, absolute CD34+ count, and infused CD34+ dose compared with the Nivestym group. For donors aged 35 years or younger, the median CD34+ dose was higher in donors who received Neupogen compared with Nivestym (6.9 vs. 6.3 million cells/kg, p = .044).ConclusionsNivestym demonstrated similar efficacy for PBSC mobilization compared with Neupogen among allo‐HSCT donors. In donors aged 35 years or younger, a slightly lower PBSC product CD34+ count was noted with Nivestym compared with Neupogen.

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Section: Introductionmentioning

confidence: 99%

Comparison of biosimilar filgrastim and originator filgrastim for peripheral blood stem cell mobilization for allogeneic hematopoietic stem cell transplantation

Shahzad,

Amin,

Bellman

et al. 2024

Transfusion

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Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

et al. 2021

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Comparing the effectiveness of biosimilar filgrastim (Nivestim®) versus original filgrastim (Neupogen®) for stem cell mobilization in adult and pediatric healthy donors

Muffarrej

Hashem

Tbakhi

et al. 2023

J Oncol Pharm Pract

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Introduction Filgrastim is used for the mobilization of stem cells in healthy donors. Though several biosimilar filgrastim products have been approved, there is limited literature evaluating biosimilar products for stem cell mobilization. Therefore, we conducted this study to compare the effectiveness of the original filgrastim, Neupogen®, to the biosimilar product, Nivestim®, for stem cell mobilization(SCM) in healthy donors. Methods This was a retrospective study that included all healthy donors: adults and pediatrics, who received Neupogen® or Nivestim® for stem cell mobilization between 2014 and 2016 at a comprehensive cancer center. Donors received filgrastim at a dose of 5 mcg/kg every 12 h for 4 days to achieve the target CD34 + cell count of 5–10 × 106 CD34 + /kg of recipient body weight. Additional doses of filgrastim were administered and/or the dose increased if target CD34 + was not achieved. The primary endpoint was the number of doses required to achieve the target CD34 + cell count. Results Over the study period, 89 donors received Neupogen® and 68 received Nivestim®. The median age of donors was 19.5 years (3–64) in the Nivestim® group and 15 years (2–16) in the Neupogen® group. The median number of doses required for SCM was eight doses (6–10) in the Nivestim group and eight (6–16) in the Neupogen® group. Conclusion Biosimilar Nivestim® was as effective as the original, Neupogen®, for stem cell mobilization for healthy adult and pediatric donors. Larger randomized studies are necessary to evaluate the safety and transplant outcomes of the use of Nivestim®.

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Efficacy and Safety of Nivestim Versus Neupogen for Mobilization of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation

Cited by 3 publications

References 13 publications

Comparison of biosimilar filgrastim and originator filgrastim for peripheral blood stem cell mobilization for allogeneic hematopoietic stem cell transplantation

Comparison of biosimilar filgrastim and originator filgrastim for peripheral blood stem cell mobilization for allogeneic hematopoietic stem cell transplantation

Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Comparing the effectiveness of biosimilar filgrastim (Nivestim®) versus original filgrastim (Neupogen®) for stem cell mobilization in adult and pediatric healthy donors

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