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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/29667324/estimation-of-cost-savings-between-2011-and-2014-attributed-to-infliximab-biosimilar-in-the-south-korean-healthcare-market-real-world-evidence-using-a-nationwide-database
#1
Jiyoun Kim, Dongmun Ha, Inmyung Song, Haesun Park, Sang-Won Lee, Eui-Kyung Lee, Ju-Young Shin
AIM: The introduction of biosimilars is expected to reduce the cost of biologic drugs, but the actual cost savings have not yet been quantified in Korea. The aim of this study was to estimate the annual cost savings attributed to the introduction of infliximab biosimilar. METHODS: We conducted a retrospective analysis using data from the Health Insurance Review and Assessment Service-National Patients Sample (HIRA-NPS) between 2011 and 2014. The study subjects were patients who were treated with infliximab, adalimumab or etanercept...
April 17, 2018: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/29643301/current-mass-spectrometric-tools-for-the-bioanalyses-of-therapeutic-monoclonal-antibodies-and-antibody-drug-conjugates
#2
Kenichiro Todoroki, Tomohiro Yamada, Hajime Mizuno, Toshimasa Toyo'oka
The increase in the use of therapeutic monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) has made the detailed bioanalysis of these drugs essential not only for planning optimal therapeutic programs for clinical practice, but also for evaluating the biological equivalencies in the development of other biosimilars. The ligand binding assays that are widely in use now are being replaced rapidly by the highly accurate, sensitive, and selective analytical method using a mass spectrometer. This review will discuss the progress in and challenges observed during the development of a mass spectrometry-based bioanalytical method for therapeutic mAbs and ADCs...
2018: Analytical Sciences: the International Journal of the Japan Society for Analytical Chemistry
https://www.readbyqxmd.com/read/29623492/therapy-for-crohn-s-disease-a-review-of-recent-developments
#3
REVIEW
Gregory J Eustace, Gil Y Melmed
PURPOSE OF REVIEW: To review recent advances in the treatment of Crohn's disease. RECENT FINDINGS: Several key advances are highlighted, including the increasing role of treatment algorithms and where new therapies can be used most effectively, the appropriate use of therapeutic drug monitoring, optimal management of post-surgical patients, and the role of multi-disciplinary clinics. The last several years have seen a number of exciting developments in the field of Crohn's therapy...
April 5, 2018: Current Gastroenterology Reports
https://www.readbyqxmd.com/read/29608867/an-evaluation-of-psoriasis-patient-perceptions-and-understanding-of-biosimilars-a-canadian-survey-comparing-biologic-and-nonbiologic-users
#4
Arvin Ighani, Jane Y Wang, Morris F Manolson
No abstract text is available yet for this article.
March 1, 2018: Journal of Cutaneous Medicine and Surgery
https://www.readbyqxmd.com/read/29606564/serum-concentrations-after-switching-from-originator-infliximab-to-the-biosimilar-ct-p13-in-patients-with-quiescent-inflammatory-bowel-disease-secure-an-open-label-multicentre-phase-4-non-inferiority-trial
#5
Anne S Strik, Wim van de Vrie, Joanne P J Bloemsaat-Minekus, Michael Nurmohamed, Peter J J Bossuyt, Alexander Bodelier, Theo Rispens, Yvonne J B van Megen, Geert R D'Haens
BACKGROUND: Biological treatment of chronic inflammatory diseases has improved patient outcomes but increased health-care costs. Switching patients from originator infliximab to a biosimilar can reduce costs, but prospective data about pharmacokinetics and potential immunogenicity are scarce. We aimed to show that infliximab serum concentrations with biosimilar CT-P13 are non-inferior to those with originator infliximab after switching from originator infliximab in patients with inflammatory bowel disease...
March 29, 2018: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29605234/-biological-and-biosimilar-drugs-clarifying-concepts
#6
EDITORIAL
Dolores Rodriguez Cumplido, Carmen Asensio Ostos
No abstract text is available yet for this article.
March 28, 2018: Atencion Primaria
https://www.readbyqxmd.com/read/29582617/real-world-use-of-biological-drugs-in-patients-with-psoriasis-psoriatic-arthritis-a-retrospective-population-based-study-from-southern-italy-in-the-years-2010-2014
#7
Ilaria Marcianò, Maria P Randazzo, Paolo Panagia, Rosanna Intelisano, Carmela Sgroi, Valentina Ientile, Serafinella Cannavò, Claudio Guarneri, Paolina Reitano, Edoardo Spina, Gianluca Trifirò
BACKGROUND: Biological drugs, such as infliximab, etanercept, adalimumab, ustekinumab, golimumab and certolizumab are third-line therapy for psoriasis (PsO) and psoriatic arthritis (PsA), but they may be used at earlier stage in severe forms. This study investigated the pattern of use and costs of biological drugs for PsO/PsA in a large population from Southern Italy during the years 2010-2014. METHODS: This was a retrospective, population-based, drug-utilization study, using healthcare administrative databases of the Local Health Unit and two hospitals of Messina Province (Sicily) in the years 2010-2014...
March 26, 2018: Giornale Italiano di Dermatologia e Venereologia: Organo Ufficiale, Società Italiana di Dermatologia e Sifilografia
https://www.readbyqxmd.com/read/29574193/nonclinical-assessments-of-the-potential-biosimilar-pf-06439535-and-bevacizumab
#8
Marjorie A Peraza, Karen E Rule, Michael H I Shiue, Gregory L Finch, Stéphane Thibault, Paul R Brown, David W Clarke, Michael W Leach
Bevacizumab, a recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF), is approved for treatment of metastatic colorectal cancer, nonsquamous non-small-cell lung cancer, metastatic kidney cancer, and glioblastoma. To support clinical development of the potential bevacizumab biosimilar PF-06439535, nonclinical studies evaluated structural, functional, toxicological, and toxicokinetic similarity to bevacizumab sourced from the European Union (bevacizumab-EU) and United States (bevacizumab-US)...
March 21, 2018: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29558865/gp2015-as-a-promising-therapy-for-rheumatoid-arthritis
#9
John Fitton, Alessandro Giollo, Maya H Buch
Rheumatoid arthritis is a common inflammatory joint disease with a myriad of systemic manifestations. Over the last 20 years its treatment has been revolutionised by the introduction of a number of different biologic drugs, including the TNF-receptor Fc fusion protein, Etanercept. However, these drugs are expensive and their widespread use puts a financial burden on healthcare systems. As many biologic treatments begin to come off patent new 'biosimilar' versions are being developed which can lead to significant cost savings...
April 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29556960/comprehensive-physicochemical-and-biological-characterization-of-the-proposed-biosimilar-darbepoetin-alfa-lbde-and-its-originator-darbepoetin-alfa-nesp-%C3%A2
#10
Yeong Ran Jeong, Rae Ung Jeong, Jeong Hyun Son, Joon Cheol Kwon, Saem Jung, Mi A Song, Jin Ah Hwang, Gyun Min Lee
BACKGROUND: For regulatory approval, the comparability of a biosimilar product to an originator product should be ensured through thorough physicochemical and biological characterization. OBJECTIVE: To evaluate the biosimilarity between LBDE, the proposed biosimilar darbepoetin alfa, and NESP® , its originator, we performed a comprehensive physicochemical and biological characterization study. METHODS: Primary and higher-order protein structures were analyzed using Lys-C peptide mapping with liquid chromatography-mass spectrometry (LC-MS), disulfide bond identification, circular dichroism, and fluorescence spectroscopy...
March 19, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29553864/analytical-and-functional-similarity-of-amgen-biosimilar-abp-215-to-bevacizumab
#11
Neungseon Seo, Alla Polozova, Mingxuan Zhang, Zachary Yates, Shawn Cao, Huimin Li, Scott Kuhns, Gwendolyn Maher, Helen J McBride, Jennifer Liu
ABP 215 is a biosimilar product to bevacizumab. Bevacizumab acts by binding to vascular endothelial growth factor A, inhibiting endothelial cell proliferation and new blood vessel formation, thereby leading to tumor vasculature normalization. The ABP 215 analytical similarity assessment was designed to assess the structural and functional similarity of ABP 215 and bevacizumab sourced from both the United States (US) and the European Union (EU). Similarity assessment was also made between the US- and EU-sourced bevacizumab to assess the similarity between the two products...
March 19, 2018: MAbs
https://www.readbyqxmd.com/read/29549597/biosimilar-drugs-for-psoriasis-principles-present-and-near-future
#12
REVIEW
Jose-Manuel Carrascosa, Ira Jacobs, Danielle Petersel, Robert Strohal
Psoriasis is a chronic, inflammatory, lifelong disease with a high prevalence (afflicting approximately 1-5% of the population worldwide) and is associated with significant morbidity. The introduction of biologic therapies has improved the management of this disease. Multiple biologic medicines that block cytokine signaling, including tumor necrosis factor (TNF) antagonists (adalimumab, etanercept, and infliximab) and inhibitors of interleukin (IL)-17 (brodalumab, ixekizumab, and secukinumab), IL-23 (guselkumab), or IL-12/23 (ustekinumab), are approved for the treatment of psoriasis...
March 16, 2018: Dermatology and Therapy
https://www.readbyqxmd.com/read/29546072/patient-access-unmet-medical-need-expected-benefits-and-concerns-related-to-the-utilisation-of-biosimilars-in-eastern-european-countries-a-survey-of-experts
#13
Andras Inotai, Marcell Csanadi, Guenka Petrova, Maria Dimitrova, Tomasz Bochenek, Tomas Tesar, Kristina York, Leos Fuksa, Alexander Kostyuk, Laszlo Lorenzovici, Vitaly Omelyanovskiy, Katalin Egyed, Zoltan Kalo
This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars...
2018: BioMed Research International
https://www.readbyqxmd.com/read/29524439/physicochemical-characterization-of-e-coli-derived-human-serum-albumin-and-its-comparison-with-the-human-plasma-counterpart-reveals-it-as-a-promising-biosimilar
#14
Ashima Sharma, Tapan K Chaudhuri
Human serum albumin one of the most demanded proteins possess an array of clinical and biotechnological applications. Currently, the prime source for HSA production is the human blood which possesses the risk of pathogen contamination and is limited. Thus, there exists an indispensable need to promote non-animal derived HSA production. In the present work, we have exploited the opportunity and promoted the preparation of pathogen-free rHSA from the E. coli host which is blessed with numerous advantages like scalability, cost-effectiveness etc...
March 7, 2018: Journal of Biotechnology
https://www.readbyqxmd.com/read/29513612/on-sample-size-requirement-for-analytical-similarity-assessment
#15
Yi Zhao, Yu-Wei Chang, Shein-Chung Chow
For approval of biosimilar products, the U.S. Food and Drug Administration (FDA) recommends a stepwise approach for obtaining the totality-of-the-evidence for assessing biosimilarirty between a proposed biosimilar product and its corresponding innovative (reference) biologic product. The stepwise approach starts with the assessment of analytical similarity of critical quality attributes (CQAs) for structural/physicochemical and functional properties in the manufacturing process of biosimilar products. For Tier 1 CQAs which are most relevant to clinical outcomes, the FDA recommends an equivalence test be performed for similarity assessment based on an equivalence acceptance criterion (EAC)...
March 7, 2018: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/29511561/cost-effectiveness-of-biological-treatment-sequences-for-fistulising-crohn-s-disease-across-europe
#16
Petra Baji, László Gulácsi, Valentin Brodszky, Zsuzsanna Végh, Silvio Danese, Peter M Irving, Laurent Peyrin-Biroulet, Stefan Schreiber, Fanni Rencz, Péter L Lakatos, Márta Péntek
Background: In clinical practice, treatment sequences of biologicals are applied for active fistulising Crohn's disease, however underlying health economic analyses are lacking. Objective: The purpose of this study was to analyse the cost-effectiveness of different biological sequences including infliximab, biosimilar-infliximab, adalimumab and vedolizumab in nine European countries. Methods: A Markov model was developed to compare treatment sequences of one, two and three biologicals from the payer's perspective on a five-year time horizon...
March 2018: United European Gastroenterology Journal
https://www.readbyqxmd.com/read/29502007/comprehensive-glycan-analysis-of-twelve-recombinant-human-erythropoietin-preparations-from-manufacturers-in-china-and-japan
#17
Ben Cowper, Xiang Li, Lei Yu, Yong Zhou, W H Fan, C M Rao
Recombinant, human, erythropoietin (rhEPO) is a glycoprotein hormone which is prescribed throughout the world to treat anaemia caused by chronic kidney disease or chemotherapy. rhEPO is at the forefront of the recent emergence of biosimilar medicines, with numerous products now available worldwide. Due to its complex glycosylation profile, which has a crucial influence upon biological activity, therapeutic rhEPO preparations must be closely monitored to ensure consistency, safety and efficacy. Here, we have compared twelve rhEPO preparations from eleven manufacturers in China and one in Japan, measuring in vivo biological activity and exploring its relationship with glycosylation through sialic acid content determination, isoform distribution via capillary electrophoresis (CE), O-glycan profiling, and N-glycan mapping using a novel anion-exchange/hydrophilic interaction chromatography-mass spectrometry (AEX/HILIC-MS) approach...
February 24, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29500617/epoetin-biosimilars-in-the-treatment-of-renal-anemia-what-have-we-learned-from-a-decade-of-european-experience
#18
David Goldsmith, Frank Dellanna, Martin Schiestl, Andriy Krendyukov, Christian Combe
Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Complementing in vitro and preclinical characterization, and pharmacokinetic/pharmacodynamic studies, clinical trials provided the additional data needed to reassure European authorities that biosimilar epoetins were sufficiently similar to the reference epoetin to warrant approval...
March 2, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29500555/switching-reference-medicines-to-biosimilars-a-systematic-literature-review-of-clinical-outcomes
#19
REVIEW
Hillel P Cohen, Andrew Blauvelt, Robert M Rifkin, Silvio Danese, Sameer B Gokhale, Gillian Woollett
INTRODUCTION: To evaluate the possibility that switching from reference biologic medicines to biosimilars could lead to altered clinical outcomes, including enhanced immunogenicity, compromised safety, or diminished efficacy for patients, a systematic literature review was conducted of all switching studies between related biologics (including biosimilars). METHODS: A systematic search was conducted using the Medline® and Embase® databases up to 30 June 2017 employing specific medical subject heading terms...
March 3, 2018: Drugs
https://www.readbyqxmd.com/read/29492747/biosimilars-in-the-treatment-of-inflammatory-bowel-disease-supporting-evidence-in-2017
#20
REVIEW
Frank I Scott, Gary R Lichtenstein
PURPOSE OF REVIEW: Monoclonal antibodies targeting tumor necrosis factor-alpha, integrin molecules, and interleukin-12/23 have become backbone therapies for Crohn's disease and ulcerative colitis. While clinically effective, these biologic therapies come with significant expense, contributing to overall healthcare spending in the USA. Biosimilars have the potential to significantly reduce expenditures secondary to the use of biologic medications such as infliximab and adalimumab, though their complicated manufacturing process results in inherent differences in structure when compared to the originator compounds...
March 1, 2018: Current Treatment Options in Gastroenterology
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