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biosimilars and bmt

Kaito Harada, Yuta Yamada, Tatsuya Konishi, Akihito Nagata, Toshiaki Takezaki, Satoshi Kaito, Shuhei Kurosawa, Masahiro Sakaguchi, Shunichiro Yasuda, Kosuke Yoshioka, Kyoko Watakabe-Inamoto, Aiko Igarashi, Yuho Najima, Takeshi Hagino, Hideharu Muto, Takeshi Kobayashi, Noriko Doki, Kazuhiko Kakihana, Hisashi Sakamaki, Kazuteru Ohashi
From January 2012 to September 2015, 49 patients received biosimilar filgrastim (BF) after allogeneic bone marrow transplantation (BMT, n = 31) or peripheral stem cell transplantation (PBSCT, n = 18) in our institution. To evaluate the clinical impact of BF on transplant outcomes of these patients, we compared hematological recovery, overall survival (OS), disease-free survival (DFS), transplantation-related mortality (TRM), cumulative incidence of relapse (CIR), and acute and chronic graft-versus-host disease (GVHD) with those of control patients who received originator filgrastim (OF) after BMT (n = 31) or PBSCT (n = 18)...
December 2016: International Journal of Hematology
Hannah A Blair, Lesley J Scott
Tbo-filgrastim (filgrastim XM02; Biograstim(®), Ratiograstim(®), Tevagrastim(®)) is approved in the EU as a biosimilar of filgrastim (Neupogen(®)) for use in all indications for which reference filgrastim is approved, including chemotherapy-induced neutropenia, neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation, mobilization of peripheral blood stem cells (PBSCs), severe chronic neutropenia, and neutropenia in HIV infection. Tbo-filgrastim (Granix(®)) is also approved as a biologic in the USA for neutropenia associated with chemotherapy...
April 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Simona Bassi, Elisa M Stroppa, Carlo F Moroni, Maria C Arbasi, Elena Trabacchi, Anna Di Franco, Antonio Lazzaro, Patrizia Bernuzzi, Mauro Moretto, Annalisa Arcari, Costanza Bosi, Alessandra Riva, Luigi Cavanna, Daniele Vallisa
BACKGROUND: Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients. MATERIALS AND METHODS: With the aim of assessing the efficacy and the safety of filgrastim biosimilars in post-ASCT bone marrow recovery, we conducted a single institution, retrospective study in 56 lymphoma and myeloma patients who received filgrastim biosimilars (Tevagrastim(®) and Zarzio(®)) at standard doses from day 5...
July 2015: Blood Transfusion, Trasfusione del Sangue
M Cioch, D Jawniak, K Kotwica, M Wach, J Mańko, A Gorący, P Klimek, E Mazurkiewicz, P Jarosz, M Hus
BACKGROUND: Autologous peripheral blood stem cell transplantation (APBSCT) is the standard of therapy for patients with multiple myeloma and refractory Hodgkin's and non-Hodgkin's lymphomas. Granulocyte colony-stimulating factor (G-CSF) is widely used to accelerate hematopoietic recovery after transplantation and to reduce the morbidity and mortality associated with prolonged neutropenia. Biosimilar G-CSF is approved for the same indications as the originator G-CSF. This is one of the first reported uses of a biosimilar G-CSF for neutrophil recovery after APBSCT...
October 2014: Transplantation Proceedings
Karl Welte
INTRODUCTION: The identification, purification and molecular cloning of granulocyte colony-stimulating factor G-CSF in the 1980s; the nonclinical studies in the mid-1980s; and the subsequent development of G-CSF as a therapeutic agent in the late 1980s and 1990s have had a major influence on the treatment of many diseases. In the clinical setting, filgrastim and lenograstim are of benefit to patients receiving chemotherapy or myeloablative treatment. They have been shown to reduce morbidity and mortality in many patient populations...
July 2014: Expert Opinion on Biological Therapy
Davide Crobu, Gaia Spinetti, Rodolfo Schrepfer, Giancarlo Tonon, Gloria Saccani Jotti, Pierluigi Onali, Simona Dedoni, Gaetano Orsini, Andrea Di Stefano
BACKGROUND: Filgrastim or methionyl-granulocyte colony-stimulating factor (Met-G-CSF), is a recombinant therapeutic protein widely used to treat severe neutropenia caused by myelosuppressive drugs in patients with nonmyeloid malignancies. In addition to its role in the regulation of granulopoiesis, treatment with G-CSF is considered the standard approach to mobilize CD34 positive (CD34+) mononuclear cells for reconstituting hemopoietic ability for bone marrow transplantation. An intended biosimilar filgrastim (coded BK0023) was produced in GMP conditions by E...
February 21, 2014: BMC Pharmacology & Toxicology
Jonathan Hoggatt, Louis M Pelus
INTRODUCTION: Granulocyte colony-stimulating factor (G-CSF; filgrastim) and its pegylated form (pegfilgrastim) are widely used to treat neutropenia associated with myelosuppressive chemotherapy and bone marrow transplantation, AIDS-associated or drug-induced neutropenia, and neutropenic diseases. G-CSF facilitates restoration of neutrophil counts, decreases incidence of infection/febrile neutropenia and reduces resource utilization. G-CSF is also widely used to mobilize peripheral blood stem cells for hematopoietic transplant...
January 2014: Expert Opinion on Investigational Drugs
Jean-Christophe Ianotto, Françoise Ngo Sack, Marie-Anne Couturier, Adrian Tempescul, Nathalie Mugnier, Pascal Delepine, Gaelle Guillerm, Christian Berthou
Granulocyte-colony stimulating factors (G-CSFs) enhance bone marrow (BM) recovery after autologous stem cell transplant (ASCT) in patients with lymphoma and myeloma. Few publications exist that discuss the use of filgrastim biosimilars after ASCT. We conducted a single-center retrospective study in patients with lymphoma and myeloma treated at Brest Hospital to assess the cost reductions related to and the efficiency and safety of filgrastim biosimilars. We identified 65 patients with lymphoma or myeloma treated with filgrastim biosimilars for ASCT and compared 19 parameters of these patients, including BM recovery, side effects, infectious complications and treatment costs, with published historical data on a cohort of 50 patients treated with classic filgrastim...
January 2014: Leukemia & Lymphoma
Ralitza Boubeva, Christian Reichert, René Handrick, Claudia Müller, Jürgen Hannemann, Gerrit Borcharda
Human recombinant granulocyte colony stimulating factor (rhG-CSF) is widely used in hematology and oncology for the treatment of neutropenia, for the restoration of neutrophil production after bone marrow transplantation, for myelodysplastic syndromes, and aplastic anemia. The E. coli expression system is commonly used for fast recombinant production of rhG-CSF at a large scale. We have applied a novel autoinduction method for the batch expression of rhG-CSF to study whether this new system would increase cell mass and target-protein yield compared to conventional E...
2012: Chimia
Giovanna Andreola, Aleksandra Babic, Cristina Rabascio, Mara Negri, Giovanni Martinelli, Daniele Laszlo
Plerixafor, a CXCR4 antagonist, has shown to be effective in increasing the number of circulating stem cells, even in patients failing a previous mobilisation attempt. Recently a number of non-glycosylated recombinant human granulocyte-colony stimulating factor (G-CSF) has been clinically approved for the same indications as the originator G-CSF for comparable safety and efficacy and their reduced cost. In an attempt to provide a less toxic strategy, 14 patients affected by haematological malignancies (non-Hodgkin's lymphoma = 4, Hodgkin's disease = 2 and multiple myeloma = 8), received the combination of biosimilar filgrastim and plerixafor as a first line mobilising strategy...
February 2012: European Journal of Haematology
Giovanni Barosi, Alberto Bosi, Maria P Abbracchio, Romano Danesi, Armando Genazzani, Paolo Corradini, Fabrizio Pane, Sante Tura
No abstract text is available yet for this article.
July 2011: Haematologica
Timothy M Cox
Gaucher disease is a rare inborn error of glycosphingolipid metabolism due to deficiency of lysosomal acid β-glucocerebrosidase; the condition has totemic significance for the development of orphan drugs. A designer therapy, which harnesses the mannose receptor to complement the functional defect in macrophages, ameliorates the principal clinical manifestations in hematopoietic bone marrow and viscera. While several aspects of Gaucher disease (particularly those affecting the skeleton and brain) are refractory to treatment, enzyme (replacement) therapy has become a pharmaceutical blockbuster...
2010: Biologics: Targets & Therapy
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