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biosimilar and mobilization

Karthik Pisupati, Yuwei Tian, Solomon Okbazghi, Alexander Benet, Rose Ackermann, Michael Ford, Sergei V Saveliev, Christopher M Hosfield, Marjeta Urh, Eric Carlson, Christopher Becker, Thomas J Tolbert, Steven P Schwendeman, Brandon T Ruotolo, Anna Schwendeman
In April 2016, the Food and Drug Administration approved the first biosimilar monoclonal antibody (mAb) - Inflectra/Remsima (Celltrion) based off the original product Remicade (infliximab, Janssen). Biosimilars promise significant cost savings for patients, but the unavoidable differences between innovator and copycat biologics raise questions regarding product interchangeability. In this study, Remicade and Remsima were examined by native mass spectrometry, ion mobility and quantitative peptide mapping. The levels of oxidation, deamidation and mutation of individual amino acids were remarkably similar...
April 1, 2017: Analytical Chemistry
Hideaki Yoshimura, Masaaki Hotta, Takahisa Nakanishi, Shinya Fujita, Aya Nakaya, Atsushi Satake, Tomoki Ito, Kazuyoshi Ishii, Shosaku Nomura
BACKGROUND: Biosimilar granulocyte colony-stimulating factor (G-CSF) has recently been introduced into clinical practice. G-CSFs are used to mobilize CD34(+) cells and accelerate engraftment after transplantation. However, in Asia, particularly in Japan, data for peripheral blood stem cell (PBSC) mobilization by this biosimilar G-CSF are currently lacking. Therefore, the clinical efficacy and safety of biosimilar G-CSF for hematopoietic stem cell transplantation needs to be evaluated in a Japanese context...
2017: Journal of Blood Medicine
Petra Becker, Arnd Schwebig, Susanne Brauninger, Heike Bialleck, Beate Luxembourg, Miriam Schulz, Chrysanthi Tsamadou, Markus Wiesneth, Peter Reinhardt, Joannis Mytilineos, Christian Seidl, Sreekanth Gattu, Natalia Kaliakina, Pritibha Singh, Hubert Schrezenmeier, Erhard Seifried, Halvard Bonig
BACKGROUND: Biosimilar granulocyte-colony-stimulating factors (G-CSFs) have been available in the European Union since 2008, and Sandoz' biosimilar filgrastim was approved in the United States in March 2015 for all of the reference product's indications except acute radiation syndrome. Biosimilar G-CSFs have been largely embraced by the medical community, except for some reservations about healthy-donor stem cell mobilization, for which use outside of clinical studies was cautioned against by some members of the scientific community...
December 2016: Transfusion
Mónica León-González, Andrés A León-Peña, María Fernanda Vallejo-VIllalobos, Ana Karen Núñez-Cortés, Alejandro Ruiz-Argüelles, Guillermo J Ruiz-Argüelles
BACKGROUND: Following the release of the initial presentation of filgrastim (granulocyte colony-stimulating factor), several biosimilars have been developed worldwide. OBJECTIVE: To study the efficacy of a Mexican biosimilar granulocyte colony-stimulating factor in a single transplant center. METHODS: In a group of 19 consecutive patients with multiple sclerosis given autografts, we employed granulocyte colony-stimulating factors to mobilize stem cells from the bone marrow to the peripheral blood, either the original granulocyte colony-stimulating factor (n = 10) or a Mexican granulocyte colony-stimulating factor biosimilar (n = 9)...
July 2016: Revista de Investigación Clínica; Organo del Hospital de Enfermedades de la Nutrición
M Schmitt, J-M Hoffmann, K Lorenz, A Publicover, A Schmitt, A Nagler
BACKGROUND AND OBJECTIVES: Biosimilars of the granulocyte colony stimulating factor (G-CSF) filgrastim were approved by the European Medicines Agency (EMA) for registered indications of the originator G-CSF, including prevention and treatment of neutropenia, as well as mobilization of peripheral blood stem cells in 2008. Nevertheless, there is still an ongoing debate regarding the quality, efficacy and safety of biosimilar G-CSF. MATERIALS AND METHODS: This article is a meta-analysis of clinical studies on the use of biosimilar G-CSF for mobilization and transplantation of haematopoietic stem cells as available in public databases...
August 2016: Vox Sanguinis
Jing Fang, Catalin Doneanu, William R Alley, Ying Qing Yu, Alain Beck, Weibin Chen
In this study, we demonstrate the utility of ultra-performance liquid chromatography coupled to mass spectrometry (MS) and ion-mobility spectrometry (IMS) to characterize and compare reference and biosimilar monoclonal antibodies (mAbs) at an advanced level. Specifically, we focus on infliximab and compared the glycan profiles, higher order structures, and their host cell proteins (HCPs) of the reference and biosimilar products, which have the brand names Remicade® and Inflectra®, respectively. Overall, the biosimilar attributes mirrored those of the reference product to a very high degree...
August 2016: MAbs
Francesco Marchesi, Andrea Mengarelli
To date, two kinds of Granulocyte Colony-Stimulating Factors (G-CSF) have been approved for autologous peripheral blood hematopoietic stem cell (PBSCs) mobilization and posttransplant hematologic recovery after high-dose chemotherapy: filgrastim (originator and biosimilar) and lenograstim. Biosimilar filgrastim has been approved on the basis of comparable efficacy and safety in clinical studies where it has been used as chemotherapy-induced febrile neutropenia prophylaxis, but no specific pre-registration studies have been published in the transplant setting...
2016: Current Medicinal Chemistry
Serdar Sivgin, Esen Karakus, Muzaffer Keklik, Gokmen Zararsiz, Musa Solmaz, Leylagul Kaynar, Bulent Eser, Mustafa Cetin, Ali Unal
OBJECTIVES AND AIM: In this study, we aimed to compare the potency of different G-CSF agents including original filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) on CD34(+) cell mobilization in patients that underwent allogeneic hematopoietic stem cell transplantation (alloHSCT). PATIENTS AND METHODS: The data of 243 donors for alloHSCT recipients diagnosed with mostly acute leukemia and myelodsyplastic syndromes (MDS) were analyzed, retrospectively...
June 2016: Transfusion and Apheresis Science
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
Julia-Tatjana Maul, Frank Stenner-Liewen, Burkhardt Seifert, Sarah Pfrommer, Ulf Petrausch, Michael K Kiessling, Urs Schanz, Gayathri Nair, Axel Mischo, Christian Taverna, Adrian Schmidt, Mario Bargetzi, Roger Stupp, Christoph Renner, Panagiotis Samaras
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®)...
February 2017: Journal of Clinical Apheresis
Ivetta Danylesko, Rina Sareli, Nira Bloom-Varda, Ronit Yerushalmi, Noga Shem-Tov, Avichai Shimoni, Arnon Nagler
Human recombinant granulocyte colony-stimulating factor (G-CSF), filgrastim (Neupogen; Amgen, Thousand Oaks, CA, USA), has been widely used for the mobilization of CD34(+) hematopoietic stem cells (HSC) from healthy donors. The experience with biosimilar G-CSF agents in this area is limited. We performed a prospective study assessing Tevagrastim (biosimilar filgrastim, XMO2; Teva, Israel) for mobilization of CD34(+) peripheral blood HSC in HLA-matched healthy sibling donors for transplantation in 24 patients with acute myelogenous leukemia (AML) and high-risk myelodysplastic syndromes (MDS) (NCT01542944)...
February 2016: Biology of Blood and Marrow Transplantation
Massimo Martino, Anna Grazia Recchia, Tiziana Moscato, Roberta Fedele, Santo Neri, Massimo Gentile, Caterina Alati, Iolanda Donatella Vincelli, Eugenio Piro, Giuseppa Penna, Caterina Musolino, Francesca Ronco, Stefano Molica, Fortunato Morabito
BACKGROUND AIMS: Filgrastim and lenograstim are the standard granulocyte colony-stimulating factor (G-CSF) agents for peripheral blood stem cell mobilization (PBSC) in patients who undergo autologous stem cell transplantation. METHODS: To assess whether biosimilars are effective, we conducted a single-center, prospective study that included 40 consecutive de novo multiple myeloma patients who received cyclophosphamide 4 g/m(2) per day plus biosimilar filgrastim G-CSF to mobilize PBSC...
October 2015: Cytotherapy
Tina Pham, Sushrut Patil, Shaun Fleming, Sharon Avery, Patricia Walker, Andrew Wei, David Curtis, Georgia Stuart, Daniela Klarica, Maureen O'Brien, Karen Morris, Tongted Das, Geraldine Bollard, Jennifer Muirhead, John Coutsouvelis, Andrew Spencer
BACKGROUND: Nivestim is a biosimilar approved for the same indications as Neupogen including the mobilization of autologous peripheral blood stem cells (PBSCs). The clinical efficacy and safety of Nivestim for this use have not been formally assessed in clinical trials. STUDY DESIGN AND METHODS: In our retrospective single-center study we compared variables of PBSC mobilization and engraftment of 60 patients mobilized with Nivestim to that of 38 patients mobilized with Neupogen...
November 2015: Transfusion
Francesco Marchesi, Michele Vacca, Svitlana Gumenyuk, Annino Pandolfi, Daniela Renzi, Francesca Palombi, Francesco Pisani, Atelda Romano, Antonio Spadea, Francesco Ipsevich, Susanna Santinelli, Mafalda De Rienzo, Elena Papa, Marco Canfora, Lamberto Laurenzi, Maria Laura Foddai, Luca Pierelli, Andrea Mengarelli
No abstract text is available yet for this article.
July 18, 2015: Leukemia & Lymphoma
María Luisa Antelo, Amaya Zabalza, María Piva Sánchez Antón, Saioa Zalba, Mariví Aznar, Cristina Mansilla, Natalia Ramírez, Eduardo Olavarría
Peripheral blood progenitor cells (PBPCs) have become the major source of hematopoietic progenitor cells for allogeneic transplantation. In February 2008, Zarzio® was approved by the European Medicine Agency for PBPCs mobilization, but this authorization was not based in trials analyzing safety and efficacy for PBPCs mobilization. Since August 2011, Zarzio® has been used at our institution for PBPCs mobilization. In total 36 healthy family donors underwent PBPCs mobilization, 18 with Neupogen® and 18 with Zarzio®...
February 2016: Journal of Clinical Apheresis
Shab Uddin, Pippa Russell, Maresa Farrell, Barbara Davy, Joe Taylor, Samir G Agrawal
OBJECTIVES: Biosimilar filgrastim was compared with lenograstim for autologous haematopoietic stem-cell transplant (HSCT) in patients with haematological malignancies. Data from a separate group of sibling donors who underwent allogeneic HSCT are also reported. METHODS: Patients with lymphoma or multiple myeloma (MM) who underwent autologous HSCT with biosimilar filgrastim were compared with a historical control group of patients who received lenograstim. Peripheral blood (PB) cells counts were monitored after 7-8 consecutive days of granulocyte-colony stimulating factor (G-CSF) injection and apheresis was performed on day 8 if PB CD34+ cell count was ⩾10 cells/µl...
April 2015: Therapeutic Advances in Hematology
Alain Beck, François Debaene, Hélène Diemer, Elsa Wagner-Rousset, Olivier Colas, Alain Van Dorsselaer, Sarah Cianférani
The approval process for antibody biosimilars relies primarily on comprehensive analytical data to establish comparability and high similarity with the originator. Mass spectrometry (MS) in combination with liquid chromatography (LC) and electrophoretic methods are the corner stone for comparability and biosimilarity evaluation. In this special feature we report head-to-head comparison of trastuzumab and cetuximab with corresponding biosimilar and biobetter candidates based on cutting-edge mass spectrometry techniques such as native MS and ion-mobility MS at different levels (top, middle and bottom)...
February 2015: Journal of Mass Spectrometry: JMS
Simone Cesaro, Gloria Tridello, Arcangelo Prete, Sandro Dallorso, Elisa Cannata, Erika Massaccesi, Marco Risso, Massimiliano De Bortoli, Désirée Caselli
BACKGROUND: Recently biosimilars of granulocyte-colony-stimulating factor (G-CSF) became available for prophylaxis and treatment of postchemotherapy neutropenia and for mobilization of peripheral blood CD34+ cells for either autologous or allogeneic hematopoietic stem cell transplant. Most of the data on the mobilization efficacy and safety of biosimilar G-CSF are from adult patients, whereas no data are available in pediatric patients. STUDY DESIGN AND METHODS: This was a retrospective study on cases treated at three Italian pediatric transplant centers, from January 2011 to October 2013...
February 2015: Transfusion
Halvard Bonig, Petra S Becker, Arnd Schwebig, Matthew Turner
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...
February 2015: Transfusion
Joanna Manko, Adam Walter-Croneck, Dariusz Jawniak, Norbert Grzasko, Magdalena Gorska-Kosicka, Maria Cioch, Anna Dmoszynska
BACKGROUND: Recombinant granulocyte colony-stimulating factor (G-CSF) is widely used to mobilize haematopoietic stem cells. We compared the efficacy and safety of a biosimilar G-CSF (Zarzio(®), Sandoz Biopharmaceuticals) with the originator G-CSF (Neupogen(®), Amgen) in patients with haematological malignancies. METHODS: A total of 108 patients were included in this study, 59 of whom were female (49 male), with an overall median age of 51 years (range 19-69). Patients had multiple myeloma (n=46), non-Hodgkin's lymphoma (n=28), Hodgkin's lymphoma (n=26), or other diagnosis (n=8)...
April 2014: Pharmacological Reports: PR
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