نتایج جستجو برای: biosimilar

تعداد نتایج: 1870  

Journal: :Advances in experimental medicine and biology 2015
Subhash Basu Rui Ma Joseph R Moskal Manju Basu

© Springer International Publishing Switzerland 2015 A. Chakrabarti, A. Surolia (eds.), Biochemical Roles of Eukaryotic Cell Surface Macromolecules, Advances in Experimental Medicine and Biology 842, DOI 10.1007/978-3-319-11280-0_21 Chapter 21 Regulations of Glycolipid: XI. Glycosyltransferase (GSL: GLTs) Genes Involved in SA-LeX and Related GSLs Biosynthesis in Carcinoma Cells by Biosimilar Ap...

Journal: :JAMA 2015
Matthew Frankel James McKay

Theauthors suggested that biosimilar qualitymight be inconsistent over time and suggested that track-and-trace capabilities might encourage consistent quality. Product quality is tightly regulatedby theFDA, both for referencebiologics and biosimilars. Each batch of every biologic must meet predetermined release specificationsbefore it canbeused to treat patients. These tight regulatory requirem...

2017
Jesús Troya Guillermo Cuevas Pablo Ryan Victorino Díez Elsa Izquierdo Ismael Escobar Javier Solís

Immune reconstitution inflammatory syndrome can present as a paradoxical reaction after initiation of antiretroviral treatment in patients with severe immunosuppression and underlying infections. Immune reconstitution inflammatory syndrome has often been associated with mycobacteria, and the clinical response to traditional treatment with corticosteroids is not always satisfactory. Consequently...

2017
Won Park Dae Hyun Yoo Pedro Miranda Marek Brzosko Piotr Wiland Sergio Gutierrez-Ureña Helena Mikazane Yeon-Ah Lee Svitlana Smiyan Mie-Jin Lim Vladimir Kadinov Carlos Abud-Mendoza HoUng Kim Sang Joon Lee YunJu Bae SuYeon Kim Jürgen Braun

OBJECTIVES To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS). METHODS This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered in...

Journal: :Pharmacoepidemiology and drug safety 2017
Amy Hemmington Nicola Dalbeth Paul Jarrett Alan G Fraser Reuben Broom Peter Browett Keith J Petrie

PURPOSE Biosimilars are a cost-effective alternative to biologics that could improve patients' access to expensive biological medicines. Currently, there are little data on doctors' perceptions of biosimilars and in what situations they are comfortable prescribing biosimilars. In this study, we investigated medical specialists' perceptions of biosimilars and the factors associated with the acce...

Journal: :Journal of Tumor Medicine & Prevention 2017

Journal: :Pharmaceutica Analytica Acta 2015

2014
Paulo D. Picon Suzane Cristina M. Pribbernow Carlos A. Prompt Suzana C. Schacher Veronica V. H. Antunes Bianca P. Mentz Fabiane L. Oliveira Celia Mariana B. de Souza Fernando C. Schacher

OBJECTIVES Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available produ...

2017
K. Blackwell P. Gascon C. M. Jones A. Nixon A. Krendyukov R. Nakov Y. Li N. Harbeck

Background Following the functional and physicochemical characterization of a proposed biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar safety and efficacy to the reference product in a sensitive patient population. Patients and methods LA-EP2006 is a proposed biosimilar that has been developed for pegfilgrastim, a long-acting form of granulocyte...

2017
Emma Sullivan James Piercy John Waller Christopher M Black Sumesh Kachroo

OBJECTIVES This study examined gastroenterologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to biosimilars. METHODS Data were taken from the Adelphi Real World Biosimilars Programme, a real-world, cross-sectional study undertaken in 2015-2016 with German gastroenterologists and patients w...

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