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https://www.readbyqxmd.com/read/28230618/biopharmaceuticals-reference-products-and-biosimilars-to-treat-inflammatory-diseases
#1
Ann Gils, Antonio Bertolotto, Denis Mulleman, Theodora Bejan-Angoulvant, Paul J Declerck
Biopharmaceuticals are primarily therapeutic proteins developed to perform specific functions by acting on the disease pathophysiology. Compared to low molecular chemically synthesized drugs, production of biopharmaceuticals is much more complex and routes of administration and pharmacokinetics differ. Biopharmaceuticals are blockbusters in the treatment of inflammatory diseases such as psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases, and the introduction of these drugs has revolutionized treatment...
February 20, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28230453/letter-draft-fda-guidance-considerations-in-demonstrating-interchangeability-with-a-reference-product-overview-and-presentation-related-concerns
#2
Elan Rubinstein
Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28214924/characteristics-and-outcomes-of-rheumatoid-arthritis-patients-who-started-biosimilar-infliximab
#3
Yoon-Kyoung Sung, Soo-Kyung Cho, Dam Kim, Soyoung Won, Chan-Bum Choi, So-Young Bang, Seung-Jae Hong, Hyoun Ah Kim, Eun-Mi Koh, Hye-Soon Lee, Chang-Hee Suh, Dae-Hyun Yoo, Sang-Cheol Bae
To compare the characteristics of rheumatoid arthritis (RA) patients receiving either biosimilar or originator infliximab and to identify the effectiveness and safety of biosimilar infliximab in RA patients in real-world practice. RA patients who started either biosimilar or originator infliximab were selected using the prospective biologic disease-modifying anti-rheumatic drugs (DMARDs) registry: BIOlogics Pharmacoepidemiologic StudY (BIOPSY). Baseline characteristics of the two groups were compared, and short-term treatment outcomes, including DAS28-ESR and HAQ-DI scores, were compared after initiation of biosimilar or originator infliximab...
February 18, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28214611/biosimilars-in-the-european-union-from-comparability-exercise-to-real-world-experience-what-we-achieved-and-what-we-still-need-to-achieve
#4
EDITORIAL
Cristina Scavone, Liberata Sportiello, Liberato Berrino, Francesco Rossi, Annalisa Capuano
No abstract text is available yet for this article.
February 15, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28210866/cost-effectiveness-of-insulin-degludec-versus-insulin-glargine-in-adults-with-type-1-and-type-2-diabetes-mellitus
#5
Marc Evans, Barrie Chubb, Jens Gundgaard
INTRODUCTION: To estimate the cost-effectiveness of insulin degludec (IDeg) versus insulin glargine U100 (IGlar U100) and new-to-market basal insulin analogues in patients with diabetes in order to aid decision-making in a complex basal insulin market. METHODS: A simple, short-term model was used to evaluate the costs and effects of treatment with IDeg versus IGlar U100 over a 12-month period in patients with type 1 (T1DM) and type 2 diabetes (T2DM) from the perspective of the UK National Health Service...
February 16, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28209290/efficacy-safety-and-pharmacokinetics-of-biosimilars-of-anti-tumor-necrosis-factor-%C3%AE-agents-in-rheumatic-diseases-a-systematic-review-and-meta-analysis
#6
REVIEW
Yuga Komaki, Akihiro Yamada, Fukiko Komaki, Praneeth Kudaravalli, Dejan Micic, Akio Ido, Atsushi Sakuraba
OBJECTIVE: To evaluate the efficacy and safety of biosimilars of anti-tumor necrosis factor (TNF)-α agents compared to their reference agents in immune mediated diseases. METHODS: Electronic databases were searched for randomized controlled trials (RCTs) assessing the efficacy and safety of biosimilars of anti-TNF-α agents compared to their reference agents in patients with various immune mediated diseases. The outcomes were the rates of clinical response and adverse events among patients treated with biosimilars compared to their reference agents...
February 13, 2017: Journal of Autoimmunity
https://www.readbyqxmd.com/read/28208257/hydrophilic-interaction-chromatography-hyphenated-with-mass-spectrometry-a-powerful-analytical-tool-for-the-comparison-of-originator-and-biosimilar-therapeutic-monoclonal-antibodies-at-the-middle-up-level-of-analysis
#7
Valentina D'Atri, Szabolcs Fekete, Alain Beck, Matthew Lauber, Davy Guillarme
The development and approval processes of biosimilar mAbs depend on their comparability to originators. Therefore, analytical comparisons are required to assess structural features and post-translational modifications (PTM) and thereby minimize the risk of being clinically meaningful differences between biosimilar and originator drug products. The glycosylation pattern of mAbs is considered to be an important critical quality attribute (CQA), and several analytical approaches have been proposed that facilitate characterizing and monitoring a glycosylation profile, albeit mainly at a glycan and glycopeptide level of analysis...
February 7, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28203295/management-of-anaemia-in-oncohaematological-patients-treated-with-biosimilar-epoetin-alfa-results-of-an-italian-observational-retrospective-study
#8
Giovanni Rosti, Mario Petrini, Alberto Bosi, Piero Galieni, Daniele Bernardi, Gianfranco Giglio, Laura Dorotea, Brunangelo Falini, Elvira Scelzi, Enzo Veltri, Roberto Castelli, Chiara Longagnani, Tommaso Raggi, Federico Simonetti
BACKGROUND: Many patients with solid tumours or nonmyeloid haematopoietic tumours develop symptomatic anaemia, which has a major impact on quality of life (QoL). The efficacy of erythropoiesis-stimulating agents (ESAs) in improving QoL and reducing blood transfusions has been widely demonstrated. Binocrit® (biosimilar epoetin alfa) is an ESA indicated in the European Union for treating chemotherapy-induced anaemia. The aim of this study was to investigate the effect of Binocrit® on haemoglobin (Hb) levels in anaemic cancer patients in Italian clinical practice...
January 2017: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/28201948/enbrel-and-etanercept-biosimilars-a-tale-of-two-patent-systems
#9
Peter Norman
No abstract text is available yet for this article.
February 16, 2017: Pharmaceutical Patent Analyst
https://www.readbyqxmd.com/read/28197999/parallel-experimental-design-and-multivariate-analysis-provides-efficient-screening-of-cell-culture-media-supplements-to-improve-biosimilar-product-quality
#10
David Brühlmann, Michael Sokolov, Alessandro Butté, Markus Sauer, Jürgen Hemberger, Jonathan Souquet, Hervé Broly, Martin Jordan
Rational and high-throughput optimization of mammalian cell culture media has a great potential to modulate recombinant protein product quality. We present a process design method based on parallel design-of-experiment (DoE) of CHO fed-batch cultures in 96-deepwell plates to modulate monoclonal antibody (mAb) glycosylation using medium supplements. To reduce risk of losing valuable information in an intricate joint screening, 17 compounds were separated into five different groups, considering their mode of biological action...
February 15, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28196209/an-important-step-forward-for-biosimilars-in-cancer-treatment
#11
Stephen M Schleicher, Andrew D Seidman
No abstract text is available yet for this article.
February 9, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28194337/development-of-statistics-as-a-discipline-for-clinical-research-past-present-and-future
#12
REVIEW
Chitra Lele
This article traces the history and evolution of statistics in the era of evidence based medicine, and focuses on the Indian perspective of this growth of statistics as a discipline for clinical research. Statistics will assume a more inter disciplinary form. Use of software other than SAS likely to grow further. In India, innovative statistical methods will help propel the development of biosimilars. The future is exciting with statistics being used for real world evidence, development of biosimilars, mining of adverse event data and becoming a core function in medicinal product development and lifecycle maintenance...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28192016/new-insulins-biosimilars-and-insulin-therapy
#13
Thomas Danne, Lutz Heinemann, Jan Bolinder
No abstract text is available yet for this article.
February 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28188909/extensive-preclinical-evaluation-of-an-infliximab-biosimilar-candidate
#14
M A Velasco-Velázquez, N Salinas-Jazmin, E Hisaki-Itaya, L Cobos-Puc, W Xolalpa, G Gonzalez, A Tenorio-Calvo, N Piña-Lara, L C Juarez-Bayardo, L F Flores-Ortiz, E Medina-Rivero, N O Pérez, S M Pérez-Tapia
Infliximab is therapeutic monoclonal antibody (mAb) against TNF-α employed in the treatment of immunoinflammatory diseases. The development of biosimilar mAbs is a global strategy to increase drug accessibility and reduce therapy-associated costs. Herein we compared key physicochemical characteristics and biological activities produced by infliximab and infliximab-Probiomed in order to identify functionally relevant differences between the mAbs. Binding of infliximab-Probiomed to TNF-α was specific and had kinetics comparable to that of the reference product...
February 7, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28183342/rheumatology-around-the-world-perspectives-from-australia-and-new-zealand
#15
EDITORIAL
Fiona M F McQueen
Rheumatology continues to be an exciting and vibrant specialty for specialists practising in New Zealand and Australia. Clinicians follow treat-to-target regimens to manage peripheral and axial inflammatory arthritides using conventional and biological agents, which have revolutionised management of rheumatic disease over the past two decades. However, optimal clinical practice has significant pharmacoeconomic implications which impact on health funding at a national level, and the advent of biosimilars is keenly awaited...
February 10, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28182150/evaluation-of-a-biosimilar-granulocyte-colony-stimulating-factor-filgrastim-xm02-for-peripheral-blood-stem-cell-mobilization-and-transplantation-a-single-center-experience-in-japan
#16
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
https://www.readbyqxmd.com/read/28176529/biosimilars
#17
James G Stevenson, Robert Popovian, Ira Jacobs, Susan Hurst, Lesley G Shane
OBJECTIVE: To review the scientific and regulatory aspects of biosimilar development and practical considerations for the use of biosimilars that are relevant to pharmacists. DATA SOURCES: Literature searches of PubMed and congress abstracts for publications pertaining to biosimilars were conducted from January 2016 to January 2017. Individual drug company web pages and governmental, regulatory, and other agency websites were also reviewed. STUDY SELECTION/DATA EXTRACTION: Published articles, regulatory guidelines, and other sources covering biologic/biosimilar development and approval, reporting results of biosimilar studies or survey research, and/or identifying biosimilars in development or approved for use in Europe or the United States were reviewed and included...
February 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28176515/biosimilars-in-inflammatory-bowel-disease
#18
Carla J Gargallo, Alberto Lue, Fernando Gomollón
The introduction of biologic therapies has revolutionized the treatment of inflammatory bowel disease (IBD) and has significantly improved the disease course and outcomes for many patients. Biologics are the main drivers of cost in many IBD units and biosimilars, although are not better than originators, are usually cheaper and thus can increase the availability of this type of therapy. Biosimilar are highly similar to innovator but, due to the complex structures of innovators and the variability inherent in the manufacturing process, they are no identical...
February 7, 2017: Minerva Medica
https://www.readbyqxmd.com/read/28175293/n803-accelerated-infusions-of-biosimilar-infliximab-are-safe-and-well-tolerated-and-monitoring-post-infusion-is-not-required
#19
K Robinson, A Wright, L Marshall, A Lobo
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28175254/p661-comparable-clinical-efficacy-safety-and-immunogenicity-of-infliximab-biosimilar-ct-p13-after-transition-from-reference-infliximab-remicade%C3%A2-in-children-with-established-inflammatory-bowel-disease-a-multi-centre-prospective-observational-study
#20
M Sladek, A Vultaggio, S Ghione, F Nencini, A Matucci, S Pratesi, F Zanieri, P M Maggi, M Paci, K Ponanta-Gawron, K Kulig, A Wasilewska, P Lionetti
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
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