A clinical comparison of the efficacy and safety of biosimilar G-CSF and originator G-CSF in haematopoietic stem cell mobilization

Mańko, Joanna; Walter‐Croneck, Adam; Jawniak, Dariusz; Grząśko, Norbert; Górska-Kosicka, Magdalena; Cioch, Maria; Dmoszyńska, Anna

doi:10.1016/j.pharep.2013.09.005

Cited by 29 publications

(13 citation statements)

References 8 publications

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“…In a recent published study [29], after administration of mobilizing regimens [primarily high-dose etoposide, high-dose Cy, intermediate-dose cytosine arabinoside (Ara-C) or ESHAP regimens], patients with MM, non-Hodgkin's lymphoma, Hodgkin's lymphoma or other diagnosis were randomly assigned to a standard daily 10 mg/kg dose of biosimilar G-CSF or originator G-CSF. Both groups had a median of one apheresis with a median time until first apheresis of 11 days.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients

Martino¹,

Recchia

Moscato³

et al. 2015

Cytotherapy

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Section: Discussionmentioning

confidence: 99%

Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients

Martino¹,

Recchia

Moscato³

et al. 2015

Cytotherapy

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“… 32 . It has been reported that cytokine concentration influences properties of stem cells 37 and more mature cells 36 , we therefore assume in the model that feedback signals act on all mitotic cell compartments.…”

Section: Methods and Model Descriptionmentioning

confidence: 99%

Mathematical modeling of the impact of cytokine response of acute myeloid leukemia cells on patient prognosis

Stiehl

Marciniak–Czochra

2018

Sci Rep

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Acute myeloid leukemia (AML) is a heterogeneous disease. One reason for the heterogeneity may originate from inter-individual differences in the responses of leukemic cells to endogenous cytokines. On the basis of mathematical modeling, computer simulations and patient data, we have provided evidence that cytokine-independent leukemic cell proliferation may be linked to early relapses and poor overall survival. Depending whether the model of cytokine-dependent or cytokine-independent leukemic cell proliferation fits to the clinical data, patients can be assigned to two groups that differ significantly with respect to overall survival. The modeling approach further enables us to identify parameter constellations that can explain unexpected responses of some patients to external cytokines such as blast crisis or remission without chemotherapy.

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“…Collectively, these studies have shown that there are no significant differences between biosimilar versus originator G‐CSF in the median number of CD34+ cells mobilized (frequency in peripheral blood or dose of apheresed CD34+ cells by body weight) or in the number of G‐CSF injections and leukapheresis procedures required to harvest the target CD34+ cell dose . Furthermore, the side effect profiles of biosimilar versus originator G‐CSF were comparable, with a similar incidence and severity of common AEs such as bone or muscle pain and headache and no severe or unexpected AEs.…”

Section: Clinical Experience With Biosimilar G‐csf In Stem Cell Mobilmentioning

confidence: 92%

Biosimilar granulocyte–colony‐stimulating factor for healthy donor stem cell mobilization: need we be afraid?

et al. 2014

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Biosimilars are approved biologics with comparable quality, safety, and efficacy to a reference product. Unlike generics, which are chemically manufactured copies of small-molecule drugs with relatively simple chemical structures, the biosimilar designation is applied to drugs that are produced by living organisms, implying much more difficult to control manufacturing and purification procedures. To account for these complexities, the European Medicines Agency (EMA), the US Food and Drug Administration, the Australian Therapeutic Goods Administration, and other regulatory authorities have devised and implemented specific, markedly more demanding pathways for the evaluation and approval of biosimilars. To date, several biosimilars have been approved, including versions of somatropin, erythropoietin, and granulocyte–colony-stimulating factor (G-CSF), and several biosimilar monoclonal antibodies are currently in development. The reference G-CSF product (Neupogen, Amgen) has been used for many years for prevention and treatment of neutropenia and also for mobilization of peripheral blood stem cells (PBSCs). However, concerns have been raised about the safety and efficacy of biosimilar G-CSF during PBSC mobilization procedures, especially in healthy donors. This article reviews the available evidence on the use of biosimilar G-CSF in this setting. Aggregate clinical evidence supports the assessment by the EMA of biosimilar and originator G-CSF as highly biologically similar, with respect to desired and undesired effects.

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A clinical comparison of the efficacy and safety of biosimilar G-CSF and originator G-CSF in haematopoietic stem cell mobilization

Abstract: A biosimilar G-CSF (Zarzio(®)) demonstrated similar efficacy and safety as the reference originator G-CSF (Neupogen(®)) in hematopoietic stem cell mobilization in patients with haematological malignancies.

Cited by 29 publications

References 8 publications

Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients

Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients

Mathematical modeling of the impact of cytokine response of acute myeloid leukemia cells on patient prognosis

Biosimilar granulocyte–colony‐stimulating factor for healthy donor stem cell mobilization: need we be afraid?

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