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Biologics/ Biosimilars

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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/28214924/characteristics-and-outcomes-of-rheumatoid-arthritis-patients-who-started-biosimilar-infliximab
#2
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/28197999/parallel-experimental-design-and-multivariate-analysis-provides-efficient-screening-of-cell-culture-media-supplements-to-improve-biosimilar-product-quality
#3
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/28188909/extensive-preclinical-evaluation-of-an-infliximab-biosimilar-candidate
#4
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
#5
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/28176529/biosimilars
#6
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
#7
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/28175208/p633-antibodies-to-infliximab-in-patients-treated-with-either-the-reference-biologic-or-the-biosimilar-ct-p13-show-identical-reactivity-towards-biosimilars-ct-p13-and-sb2-in-inflammatory-bowel-disease
#8
G Fiorino, M B Ruiz-Agüello, A Maguregui, D Nagore, S Radice, D Gilardi, C Correale, M Allocca, F Furfaro, M Alfieri, A Martínez, S Danese
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28175166/p605-rapid-detection-of-anti-infliximab-antibodies-in-inflammatory-bowel-disease-patients-treated-with-the-reference-biologic-or-the-biosimilar-ct-p13-performance-comparison-with-elisa
#9
G Fiorino, A Ametzazurra, D Nagore, A M Hernández, N Torres, S Radice, D Gilardi, C Correale, M Allocca, F Furfaro, M Alfieri, J Pascual, X Recalde, A Martínez, S Danese
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28175069/p333-changing-patterns-of-biological-therapy-use-with-the-introduction-of-biosimilars-in-inflammatory-bowel-disease
#10
K Mortier, I Arnott, R K Russell
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172698/p425-biosimilar-infliximab-in-real-life-crohn-s-disease-treatment-in-anti-tnf-alpha-na%C3%A3-ve-and-non-na%C3%A3-ve-patients-in-comparison-to-biologic-originator-a%C3%A2-comparative-observational-cohort-study
#11
M Kaniewska, A Moniuszko, K Maciejewska, G Rydzewska
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28164249/extrapolation-and-interchangeability-of-infliximab-and-adalimumab-in-inflammatory-bowel-disease
#12
REVIEW
Shannon Chang, Stephen Hanauer
Infliximab and adalimumab biosimilars have been approved by the FDA and European Medicines Agency and have already been introduced to the international market. Availability into the US market is imminent. Biosimilars are highly similar to the reference biologic product but should not be referred to as, nor equated with, generic medications as no two biosimilars can ever be identical. Regulatory pathways for biosimilar approval consider the totality of evidence for biosimilar approvals, but the preponderance of development relies on analytic and functional testing and allows extrapolation between indications to reduce the financial burden of completing comparative clinical trials for each indication...
February 6, 2017: Current Treatment Options in Gastroenterology
https://www.readbyqxmd.com/read/28151523/-equivalence-equity-and-evidence-for-the-use-of-biosimilar-drugs
#13
Francesco Trotta, Antonio Addis
At present, biosimilar drugs are one of the potential tools capable to allow the access to biological pharmacotherapy in a context of limited resources. Even though universal standards have been determined, prescribers are often unaware of the meaning of the evaluation which assures correct equivalence of biosimilar with the originator product. On the other hand, comparative efficacy and safety studies between biosimilars and originators are often lacking. These might be some of the limiting factors for a wider use of such therapeutic tools by the health practitioners...
2017: Recenti Progressi in Medicina
https://www.readbyqxmd.com/read/28147374/experience-with-biosimilar-infliximab-remsima%C3%A2-in-norway
#14
Jørgen Jahnsen, Kristin Kaasen Jørgensen
BACKGROUND: The first monoclonal antibody biosimilar to be used in clinical practice is the tumour necrosis factor-alpha inhibitor Remsima® (CT-P13). The drug is approved for all indications as the originator infliximab (Remicade®) although clinical efficacy has been demonstrated only in rheumatic diseases. Since the fall of 2013, Remsima® has been available in Norway and from January 2014, it has been the drug of choice when initiating biological treatment in biologics naïve patients with inflammatory bowel disease (IBD)...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28147370/does-the-introduction-of-biosimilars-change-our-understanding-about-treatment-modalities-for-inflammatory-bowel-disease
#15
L Buer, M L Høivik, A W Medhus, B Moum
BACKGROUND: Biological agents, mainly tumor necrosis factor-α inhibitors, play an important role in the treatment of inflammatory bowel disease (IBD). These drugs are expensive and constitute a major cost in the IBD care. In 2013, the first biosimilar monoclonal antibody, infliximab (IFX), was approved in the EU. Key Messages: There has been considerable skepticism regarding the use of biosimilars. Both clinicians and patients have questioned the safety and efficacy of these new drugs...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28147368/combining-therapeutic-drug-monitoring-with-biosimilars-a-strategy-to-improve-the-efficacy-of-biologicals-for-treating-inflammatory-bowel-diseases-at-an-affordable-cost
#16
REVIEW
Ann Gils
BACKGROUND: Biologicals provide a tight disease control but not all patients respond favourably to treatment. Some patients do not respond at all (primary non-responders), while other patients respond initially but show loss of response over time (secondary non-responders). Drug concentrations in the serum of patients can be monitored and correlated with biological, clinical or endoscopic response. Therapeutic thresholds have been defined for infliximab and adalimumab. The European Medicines Agency has approved 3 biosimilars of infliximab and new biosimilars are waiting approval...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28142147/history-of-erythropoiesis-stimulating-agents-the-development-of-biosimilars-and-the-future-of-anemia-treatment-in-nephrology
#17
Kamyar Kalantar-Zadeh
BACKGROUND: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world...
February 1, 2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28133979/the-totality-of-the-evidence-approach-to-the-development-and-assessment-of-gp2015-a-proposed-etanercept-biosimilar
#18
Vibeke Strand, Giampiero Girolomoni, Martin Schiestl, Robert Ernst Mayer, Hilke Friccius-Quecke, Mark McCamish
OBJECTIVE: The aim of this review is to describe the inherent variability that is natural to biologics and, using the proposed etanercept biosimilar (GP2015) as an example, provide details on the 'totality-of-the-evidence' concept, whereby all physicochemical, biologic, preclinical and clinical data for a biosimilar and reference medicine are evaluated in an iterative, stepwise manner and shown to be highly similar. METHODS: This review was carried out by a search of published articles, reviews, abstracts and patents in PubMed/Medline and Google Scholar up to November 2016...
January 30, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28127193/biosimilars-in-inflammatory-bowel-disease-a-review-of-post-marketing-experience
#19
REVIEW
Simona Deiana, Tommaso Gabbani, Vito Annese
Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined "boundaries of tolerance": differences in some features between the two molecules are considered important only if clinical relevant...
January 14, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28120313/interchangeability-of-biosimilars-a-european-perspective
#20
Pekka Kurki, Leon van Aerts, Elena Wolff-Holz, Thijs Giezen, Venke Skibeli, Martina Weise
Many of the best-selling 'blockbuster' biological medicinal products are, or will soon be, facing competition from similar biological medicinal products (biosimilars) in the EU. Biosimilarity is based on the comparability concept, which has been used successfully for several decades to ensure close similarity of a biological product before and after a manufacturing change. Over the last 10 years, experience with biosimilars has shown that even complex biotechnology-derived proteins can be copied successfully...
January 24, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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