Biosimilar G-CSF (filgrastim) is effective for peripheral blood stem cell mobilization and non-cryopreserved autologous transplantation

Yafour, Nabil; Brahimi, Mohamed; Osmani, Soufi; Arabi, Abdessamed; Bouhass, R.; Bekadja, Mohamed Amine

doi:10.1016/j.tracli.2013.04.109

Cited by 10 publications

(5 citation statements)

References 7 publications

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“…A few analyses have reported on the efficacy of this specific G‐CSF biosimilar for HPC mobilization but all were performed with heterogeneous small patient collectives mobilized with different regimens . It is well known that patients with different entities may differ in the rates of mobilization success as well as the rate of toxicities after autologous HPC transplantation due to varying conditioning regimens used.…”

Section: Discussionmentioning

confidence: 99%

“…But in contrast to conventional generic drugs, the characteristics and efficiency of biological therapeutics may be influenced profoundly by the manufacturing process. Therefore, equal safety and efficacy of filgrastim biosimilars compared to their original counterpart have been debated, and this resulted in the reporting of various studies, but the patient cohorts analyzed were mostly heterogeneous as were the mobilization regimens used . Here we address the timely question whether the biosimilar filgrastim Zarzio® is comparable to the original filgrastim Neupogen® when used exclusively with vinorelbine for HPC mobilization in multiple myeloma patients.…”

Section: Introductionmentioning

confidence: 99%

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Efficacious and save use of biosimilar filgrastim for hematopoietic progenitor cell chemo‐mobilization with vinorelbine in multiple myeloma patients

Maul

Stenner

Seifert

et al. 2016

J of Clinical Apheresis

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Biosimilars are increasingly being licensed as equipotent drugs, although efficacy and safety data are not available for all clinical indications. Accordingly, the efficacy of the biosimilar filgrastim Zarzio® combined with vinorelbine for chemo-mobilization of CD34+ hematopoietic progenitor cells (HPC) in patients with multiple myeloma has not been evaluated yet. We compared the efficacy of vinorelbine combined with this biosimilar filgrastim for HPC mobilization to vinorelbine plus original filgrastim (Neupogen®). Overall, 105 multiple myeloma patients received vinorelbine 35 mg/m intravenously on day 1 and either original filgrastim (n = 61;58%) or biosimilar filgrastim (n = 44;42%) at a dose of 5 µg per kg body weight (BW) twice daily subcutaneously starting day 4 until the end of the collection procedure. Leukapheresis was scheduled to start on day 8 and performed for a maximum of three consecutive days until at least 4 × 10 HPC/kg BW were collected. All patients proceeded to leukapheresis. In 102 (97%) patients the leukapheresis sessions were started as planned at day 8. The median number of collected HPC was 7.3 × 10 /kg BW (0.2-18.3) with original filgrastim compared to 9 × 10 /kg BW (4.2-23.8) with the biosimilar filgrastim (P = 0.16). HPC collection was successful in 57 (93%) of 61 patients of the original group and in all 44 (100%) patients of the biosimilar group (P = 0.14). No differences were observed regarding side effects. Duration of neutrophil engraftment after autologous HPC transplantation was similar between the two groups (P = 0.17). Biosimilar and original filgrastim achieve comparable results in combination with vinorelbine regarding HPC mobilization and transplantation outcome in multiple myeloma patients. J. Clin. Apheresis 32:21-26, 2017. © 2016 Wiley Periodicals, Inc.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacious and save use of biosimilar filgrastim for hematopoietic progenitor cell chemo‐mobilization with vinorelbine in multiple myeloma patients

Maul

Stenner

Seifert

et al. 2016

J of Clinical Apheresis

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“…Examples of such "Biologics", or generic variants thereof often referred to as "biosimilars", 8,9 include therapeutic, monoclonal antibodies (mAbs), [10][11][12][13][14] human blood clotting factors, 15,16 botulinum toxin, 17 insulin, 18 cellular growth factors, [19][20][21][22][23] and recombinant human cytokines. [24][25][26] Owing to their generally higher target specificity, such bulky biological molecules provide novel therapeutic potentials, as compared to classical small molecule drugs, 27 such as the blockbusters Fluticasone, 28 Rosuvastine, 29,30 or Aripiprazole.…”

Section: Michael Adlermentioning

confidence: 99%

Highly sensitive ligand-binding assays in pre-clinical and clinical applications: immuno-PCR and other emerging techniques

Spengler¹,

Adler²,

Niemeyer

2015

Analyst

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Recombinant DNA technology and corresponding innovations in molecular biology, chemistry and medicine have led to novel therapeutic biomacromolecules as lead candidates in the pharmaceutical drug development pipelines. While monoclonal antibodies and other proteins provide therapeutic potential beyond the possibilities of small molecule drugs, the concomitant demand for supportive bioanalytical sample testing creates multiple novel challenges. For example, intact macromolecules can usually not be quantified by mass-spectrometry without enzymatic digestion and isotopically labeled internal standards are costly and/or difficult to prepare. Classical ELISA-type immunoassays, on the other hand, often lack the sensitivity required to obtain pharmacokinetics of low dosed drugs or pharmacodynamics of suitable biomarkers. Here we summarize emerging state-of-the-art ligand-binding assay technologies for pharmaceutical sample testing, which reveal enhanced analytical sensitivity over classical ELISA formats. We focus on immuno-PCR, which combines antibody specificity with the extremely sensitive detection of a tethered DNA marker by quantitative PCR, and alternative nucleic acid-based technologies as well as methods based on electrochemiluminescence or single-molecule counting. Using case studies, we discuss advantages and drawbacks of these methods for preclinical and clinical sample testing.

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“…There are many studies concerning the clinical usage of Abbreviations: G-CSF, granulocyte colony-stimulating factor; ANC, absolute neutrophil count; PLT, platelet count. biosimilar G-CSF for primary and secondary prophylaxis of chemotherapy-induced neutropenia and peripheral blood stem cell mobilization [5,7,8], but there are only a few reports concerning application of this drug after APBSCT. Our study shows that biosimilar G-CSF (Zarzio) is a safe and well-tolerated drug.…”

Section: Discussionmentioning

confidence: 99%

Biosimilar Granulocyte Colony-Stimulating Factor Is Effective in Reducing the Duration of Neutropenia After Autologous Peripheral Blood Stem Cell Transplantation

Cioch

Jawniak

Kotwica

et al. 2014

Transplantation Proceedings

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Biosimilar G-CSF (filgrastim) is effective for peripheral blood stem cell mobilization and non-cryopreserved autologous transplantation

Cited by 10 publications

References 7 publications

Efficacious and save use of biosimilar filgrastim for hematopoietic progenitor cell chemo‐mobilization with vinorelbine in multiple myeloma patients

Efficacious and save use of biosimilar filgrastim for hematopoietic progenitor cell chemo‐mobilization with vinorelbine in multiple myeloma patients

Highly sensitive ligand-binding assays in pre-clinical and clinical applications: immuno-PCR and other emerging techniques

Biosimilar Granulocyte Colony-Stimulating Factor Is Effective in Reducing the Duration of Neutropenia After Autologous Peripheral Blood Stem Cell Transplantation

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