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https://www.readbyqxmd.com/read/29341406/biosimilars-and-haemophilia
#1
EDITORIAL
A E Thomas
No abstract text is available yet for this article.
January 2018: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/29340661/second-cancer-biosimilar-approved
#2
Rebecca Voelker
No abstract text is available yet for this article.
January 16, 2018: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/29340530/the-use-of-biosimilar-medicines-in-oncology-position-statement-of-the-brazilian-society-of-clinical-oncology-sboc
#3
G S Fernandes, C Sternberg, G Lopes, R Chammas, M A C Gifoni, R A Gil, D V Araujo
A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine...
January 11, 2018: Brazilian Journal of Medical and Biological Research, Revista Brasileira de Pesquisas Médicas e Biológicas
https://www.readbyqxmd.com/read/29339951/benefits-concerns-and-future-directions-of-biosimilars-in-inflammatory-bowel-disease
#4
Brian Feagan
No abstract text is available yet for this article.
December 2017: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29337201/on-the-glycosylation-aspects-of-biosimilarity
#5
REVIEW
László Hajba, Ákos Szekrényes, Beáta Borza, András Guttman
The recent expiration of several protein therapeutics opened the door for biosimilar development. Biosimilars are biologic medical products that are similar but not identical copies of already-authorized protein therapeutics. Critical quality attributes (CQA), such as post-translational modifications of recombinant biotherapeutics, are important for the clinical efficacy and safety of both the innovative biologics and their biosimilar counterparts. Here, we summarize biosimilarity CQAs, considering the regulatory guidelines and the statistical aspects (e...
January 11, 2018: Drug Discovery Today
https://www.readbyqxmd.com/read/29335342/comparative-efficacy-of-tumor-necrosis-factor-%C3%AE-inhibitors-in-ankylosing-spondylitis-a-systematic-review-and-bayesian-network-metaanalysis
#6
Runsheng Wang, Abhijit Dasgupta, Michael M Ward
OBJECTIVE: To compare the efficacy of 6 tumor necrosis factor-α inhibitors (TNFi) in treatment of ankylosing spondylitis (AS) at 12 weeks and 24 weeks. METHODS: We performed a systematic literature review of randomized controlled trials of TNFi in patients with active AS. We included trials that reported efficacy at 10 to 14 weeks (12-week analysis) and at 24 to 30 weeks (24-week analysis). We used Bayesian network metaanalysis (NMA) to compare their relative efficacy to improve the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and C-reactive protein (CRP) level...
January 15, 2018: Journal of Rheumatology
https://www.readbyqxmd.com/read/29330636/a-randomised-trial-comparing-the-pharmacokinetics-and-safety-of-the-biosimilar-ct-p6-with-reference-trastuzumab
#7
Francisco J Esteva, Justin Stebbing, Rebecca N Wood-Horrall, Peter J Winkle, Sung Young Lee, Sang Joon Lee
PURPOSE: Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin®) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. METHODS: We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males...
January 12, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29325754/a-comprehensive-approach-for-evaluating-charge-heterogeneity-in-biosimilars
#8
Zhiliang Xiao, Xiaohang Yin, Lina Han, Baiping Sun, Zhenduo Shen, Wanhui Liu, Fei Yu
Charge heterogeneity is often evaluated during biosimilar development as it is a universal feature of monoclonal antibodies (mAbs). A common approach in the industry is to develop a biosimilar product with a similar overall charge profile as the reference product. However, uncertainty remains with this approach as the same charge profile in two different products may be caused by different mechanisms. In this work, we present a comprehensive investigation of the charge variants of a therapeutic monoclonal antibody and its biosimilar candidate...
January 8, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29325166/drug-safety-and-immunogenicity-of-tumour-necrosis-factor-inhibitors-the-story-so-far
#9
Meghna Jani, William G Dixon, Hector Chinoy
TNF-α inhibitor (TNFi) therapies have transformed the treatment of several rheumatic musculoskeletal diseases. However, the majority of TNFi's are immunogenic and consequent anti-drug antibodies formation can impact on both treatment efficacy and safety. Several controversies exist in the area of immunogenicity of TNFis and drug safety. While anti-drug antibodies to TNFis have been described in association with infusion reactions; serious adverse events (AEs) such as thromboembolic events, lupus-like syndrome, paradoxical AEs, for example, vasculitis-like events and other autoimmune manifestations have also been reported...
January 8, 2018: Rheumatology
https://www.readbyqxmd.com/read/29324849/the-b-cell-death-function-of-obinutuzumab-hdel-produced-in-plant-nicotiana-benthamiana-l-is-equivalent-to-obinutuzumab-produced-in-cho-cells
#10
Jin Won Lee, Woon Heo, Jinu Lee, Narae Jin, Sei Mee Yoon, Ki Youl Park, Eun Yu Kim, Woo Taek Kim, Joo Young Kim
Plants have attracted attention as bio-drug production platforms because of their economical and safety benefits. The preliminary efficacy of ZMapp, a cocktail of antibodies produced in N. benthamiana (Nicotiana benthamiana L.), suggested plants may serve as a platform for antibody production. However, because the amino acid sequences of the Fab fragment are diverse and differences in post-transcriptional processes between animals and plants remain to be elucidated, it is necessary to confirm functional equivalence of plant-produced antibodies to the original antibody...
2018: PloS One
https://www.readbyqxmd.com/read/29317666/single-very-low-rituximab-doses-in-healthy-volunteers-a-pilot-and-a-randomized-trial-implications-for-dosing-and-biosimilarity-testing
#11
Christian Schoergenhofer, Michael Schwameis, Christa Firbas, Johann Bartko, Ulla Derhaschnig, Robert M Mader, Raute Sunder Plaßmann, Petra Jilma-Stohlawetz, Kalpna Desai, Priya Misra, Ulrich Jäger, Bernd Jilma
There are no  dose-finding trials available for rituximab that could guide dosing in non-malignant diseases. We hypothesized that currently used doses (≥375 mg/m2) exceed several hundred-fold the half-maximal effective dose, which is most sensitive for detecting putative differences between biosimilars and important for dose finding. In an open label, exploratory trial healthy volunteers received single infusions of rituximab at doses of 0.1, 0.3 or 1.0 mg/m2. Subsequently, in a double-blind, randomized trial healthy volunteers received single infusions of two rituximab products at doses of 0...
January 9, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29317553/safety-profile-of-biosimilar-filgrastim-zarzio-zarxio-a-combined-analysis-of-phase-iii-studies
#12
Nadia Harbeck, Pere Gascón, Andriy Krendyukov, Nadja Hoebel, Sreekanth Gattu, Kimberly Blackwell
BACKGROUND: Evaluation of adverse events (AEs) in pivotal registration trials and ongoing postmarketing surveillance is important for all biologics, including biosimilars. A combined analysis of two pivotal registration studies was performed to strengthen evidence on safety for biosimilar filgrastim EP2006 in patients with breast cancer receiving myelosuppressive chemotherapy, a sensitive clinical setting to confirm biosimilarity of filgrastim. MATERIALS AND METHODS: Data were combined from two phase III studies of biosimilar filgrastim EP2006...
January 9, 2018: Oncologist
https://www.readbyqxmd.com/read/29313926/worldwide-perspective-of-biosimilars-for-psoriasis
#13
B Kirby
No abstract text is available yet for this article.
December 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/29313024/evolving-trends-in-mab-production-processes
#14
REVIEW
Abhinav A Shukla, Leslie S Wolfe, Sigma S Mostafa, Carnley Norman
Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now routinely achieved for mAbs in mammalian cell culture...
March 2017: Bioengineering & Translational Medicine
https://www.readbyqxmd.com/read/29310493/drug-concentrations-and-anti-drug-antibodies-during-treatment-with-biosimilar-infliximab-ct-p13-in-routine-care
#15
B Glintborg, T Kringelbach, N Bolstad, D J Warren, G Eng, I J Sørensen, A G Loft, O Hendricks, Imj Hansen, A Linauskas, H Nordin, S Kristensen, H Lindegaard, D V Jensen, G L Goll, E Høgdall, J Gehin, C Enevold, C H Nielsen, N S Krogh, J S Johansen, M L Hetland
No abstract text is available yet for this article.
January 9, 2018: Scandinavian Journal of Rheumatology
https://www.readbyqxmd.com/read/29296077/hx575-established-biosimilarity-in-the-treatment-of-renal-anemia-and-10-years-of-clinical-experience
#16
REVIEW
Frank Dellanna, David Goldsmith, Andriy Krendyukov, Andreas Seidl, Nadja Höbel, Christian Combe
Erythropoiesis-stimulating agents, such as recombinant human erythropoietin, are commonly used for the treatment of anemia in patients with chronic kidney disease (CKD). In 2007, HX575 (Binocrit®) became the first biosimilar epoetin alfa to be approved by the European Medicines Agency (EMA). The decision to approve a biosimilar is based on the totality of evidence obtained in a comprehensive comparability exercise that involves extensive analytical characterization, nonclinical studies and clinical studies...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29287266/stability-of-infliximab-solutions-in-different-temperature-and-dilution-conditions
#17
Nicolas Tokhadze, Philip Chennell, Yoann Le Basle, Valerie Sautou
Infliximab is a monoclonal antibody widely used for the treatment of inflammatory diseases. Over the past few years, many studies have assessed that monoclonal antibodies are prone to aggregation under stress conditions. The aim of this study was to investigate the stability of solutions of an infliximab biosimilar (Inflectra®) at different concentrations (0.4, 2 and 10 mg/mL). These solutions were separately submitted to three temperature conditions that are likely to happen during the drug dispensing system: -20 °C, 5 °C and 25 °C...
December 18, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29285958/maintaining-consistent-quality-and-clinical-performance-of-biopharmaceuticals
#18
William C Lamanna, Johann Holzmann, Hillel P Cohen, Xinghua Guo, Monika Schweigler, Thomas Stangler, Andreas Seidl, Martin Schiestl
Biopharmaceuticals are large protein based drugs which are heterogeneous by nature due to post translational modifications resulting from cellular production, processing and storage. Changes in the abundance of different variants over time are inherent to biopharmaceuticals due to their sensitivity to subtle process differences and the necessity for regular manufacturing changes. Product variability must thus be carefully controlled to ensure that it does not result in changes in safety or efficacy. Areas Covered: The focus of this manuscript is to provide improved understanding of the science and strategies used to maintain the quality and clinical performance of biopharmaceuticals, including biosimilars, throughout their lifecycle...
December 29, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29285951/seifem-2017-from-real-life-to-an-agreement-on-the-use-of-granulocyte-transfusions-and-colony-stimulating-factors-for-prophylaxis-and-treatment-of-infectious-complications-in-patients-with-hematologic-malignant-disorders
#19
Alessandro Busca, Simone Cesaro, Luciana Teofili, Mario Delia, Chiara Cattaneo, Marianna Criscuolo, Francesco Marchesi, Nicola Stefano Fracchiolla, Caterina Giovanna Valentini, Francesca Farina, Roberta Di Blasi, Lucia Prezioso, Angelica Spolzino, Anna Candoni, Maria Ilaria Del Principe, Luisa Verga, Annamaria Nosari, Franco Aversa, Livio Pagano
The rapid spread of severe infections mainly due to resistant pathogens, justifies the search for therapies aiming to restore immune functions severely compromised in patients with hematologic malignancies. Areas covered: The present review summarizes the current knowledge on the role of granulocyte transfusions and colony-stimulating factors as treatment strategy for hematologic patients with serious infectious complications. In addition, a survey among 21 hematologic centers, to evaluate the clinical practice for the use of G-CSF originator and biosimilars was performed...
December 29, 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/29285735/recommendations-for-the-development-and-validation-of-neutralizing-antibody-assays-in-support-of-biosimilar-assessment
#20
D Gouty, C C Cai, X Y Cai, A Kasinath, V Kumar, S Alvandkouhi, J Yang, S Pederson, B Babbitt, D Peritt, A Rudy, V Koppenburg, A Dasilva, M Ullmann, S Liu, C Satterwhite
The American Association of Pharmaceutical Scientists (AAPS) biosimilar focus group on nonclinical and clinical assays has developed this manuscript to guide the industry on best practices and testing strategies when developing neutralizing antibody (NAb) assays for biosimilar programs. The immunogenicity assessment to biosimilar and originator drug products is one of the key aspects of clinical programs for biosimilars to demonstrate biosimilarity. Establishing that there are no clinically meaningful differences in immune response between a proposed product and the originator product is a key element in the demonstration of biosimilarity...
December 28, 2017: AAPS Journal
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