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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/29045077/subjective-complaints-as-main-reason-for-biosimilar-discontinuation-after-open-label-transitioning-from-originator-to-biosimilar-infliximab
#1
Lieke Tweehuysen, Bart J F van den Bemt, Iris L van Ingen, Alphons J L de Jong, Willemijn H van der Laan, Frank H J van den Hoogen, Alfons A den Broeder
OBJECTIVE: To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity and safety after transitioning treatment from originator infliximab (Remicade(®) , REM) to biosimilar infliximab (CT-P13) in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis in daily practice. METHODS: 192 of 222 REM-treated patients agreed to transition to CT-P13 and were included in this multicenter prospective cohort study. Change in DAS28-CRP, BASDAI, CRP and (anti-) infliximab levels were assessed after six months and adverse events (AEs) were documented...
October 18, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29042750/current-perspective-on-rituximab-in-rheumatic-diseases
#2
REVIEW
Tommaso Schioppo, Francesca Ingegnoli
The steadily increasing knowledge regarding pathogenetic mechanisms in autoimmune rheumatic diseases has paved the way to different therapeutic approaches. In particular, the market entry of biologics has dramatically modified the natural history of rheumatic chronic inflammatory diseases with a meaningful impact on patients' quality of life. Among the wide spectrum of available biological treatments, rituximab (RTX), first used in the treatment of non-Hodgkin's lymphoma, was later approved for rheumatoid arthritis and anti-neutrophil cytoplasmic antibodies-associated vasculitis...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29036253/understanding-state-regulation-of-biosimilars-and-effect-on-prescribers
#3
Katerina Yale, Olabola Awosika, Monica Rengifo-Pardo, Alison Ehrlich
Biologics are a mainstay of treatment for many dermatologic conditions, however the high costs can be prohibitive for many patients. A growing market of biosimilar drugs is emerging with the hope of providing patients access to more affordable medications. While the FDA has created an abbreviated licensure pathway for these drugs, states are still in the process of creating regulations regarding their substitution for reference biologics. This article looks to raise awareness of the current federal regulations and the differences among state regulations regarding the use of biosimilars...
October 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29033595/drug-tendering-drug-supply-and-shortage-implications-for-the-uptake-of-biosimilars
#4
REVIEW
George Dranitsaris, Ira Jacobs, Carol Kirchhoff, Robert Popovian, Lesley G Shane
Due to the continued increase in global spending on health care, payers have introduced a number of programs, policies, and agreements on pharmaceutical pricing in order to control costs. While incentives to increase generic drug use have achieved significant savings, other cost-containment measures are required. Tendering is a formal procedure to purchase medications using competitive bidding for a particular contract. Although useful for cost containment, tendering can lead to decreased competition in a given market...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29032452/treatment-outcomes-with-biosimilars-be-aware-of-the-nocebo-effect
#5
REVIEW
Mourad F Rezk, Burkhard Pieper
Over the years, biologic agents have proven their importance in the management of chronic autoimmune diseases, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Biosimilars, which are biologic medicines, are highly similar to approved biologic medicines, and are comprehensively developed and rigorously tested to ensure efficacy and safety are similar to the reference product. A broader armamentarium of biosimilars is expected to improve patients' access to safe and effective biologic medicines, thus offering benefits to healthcare systems around the globe...
October 14, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29024096/state-of-the-art-immunogenicity-evaluation-in-phase-3-confirmatory-study-egality-with-etanercept-biosimilar-gp2015
#6
J Poetzl, I Arlt, O von Richter, H Wöhling, M Afonso, G Schaffar
Immunogenicity is an important aspect of all biologics. Switching between biological products has triggered intensive discussion on the interchangeability of a biosimilar with its reference medicine, with the main focus being immunogenicity and different perspectives within Europe(1) and the United States.(2) Given that immunogenicity assay validation and performance characteristics differ from assay to assay, the immunogenicity assay parameters discussed here enable the interpretation of the immunogenicity results...
October 10, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/29020508/variability-of-intended-copies-for-etanercept-enbrel%C3%A2-data-on-multiple-batches-of-seven-products
#7
Brian Hassett, Morton Scheinberg, Gilberto Castañeda-Hernández, Mengtao Li, Uppuluri Rk Rao, Ena Singh, Ehab Mahgoub, Javier Coindreau, Julie O'Brien, Steven M Vicik, Brian Fitzpatrick
Fusion protein and monoclonal antibody-based tumor necrosis factor (TNF) inhibitors represent established treatment options for a range of inflammatory diseases. Regulatory authorities have outlined the structural characterization and clinical assessments necessary to establish biosimilarity of a new biotherapeutic product with the innovator biologic drug. Biologic products that would not meet the minimum World Health Organization's standard for evaluation of similar biotherapeutic products are available in some countries; in some cases relevant data to assess biosimilarity and appropriate regulatory approval pathways are lacking...
October 11, 2017: MAbs
https://www.readbyqxmd.com/read/28992449/advances-in-the-use-of-biologics-and-other-novel-drugs-for-managing-inflammatory-bowel-disease
#8
REVIEW
Sang Hyoung Park, Satimai Aniwan, Edward V Loftus
For the ultimate aim of preventing intestinal disability in inflammatory bowel disease (IBD), the treatment goal has moved from symptom control towards inflammation control (i.e., 'deep remission'). Furthermore, the concept of 'treat-to-target' has been adopted to assist in treatment escalation and better control. Although deep remission is possible with current biologics, there are still unmet needs in IBD management. Biosimilars of several biologics will be an increasingly common option in the near future...
October 6, 2017: Current Opinion in Pharmacology
https://www.readbyqxmd.com/read/28976302/certolizumab-pegol-and-secukinumab-for-treating-active-psoriatic-arthritis-following-inadequate-response-to-disease-modifying-antirheumatic-drugs-a-systematic-review-and-economic-evaluation
#9
Mark Corbett, Fadi Chehadah, Mousumi Biswas, Thirimon Moe-Byrne, Stephen Palmer, Marta Soares, Matthew Walton, Melissa Harden, Pauline Ho, Nerys Woolacott, Laura Bojke
BACKGROUND: Several biologic therapies are approved by the National Institute for Health and Care Excellence (NICE) for psoriatic arthritis (PsA) patients who have had an inadequate response to two or more synthetic disease-modifying antirheumatic drugs (DMARDs). NICE does not specifically recommend switching from one biologic to another, and only ustekinumab (UST; STELARA(®), Janssen Pharmaceuticals, Inc., Horsham, PA, USA) is recommended after anti-tumour necrosis factor failure. Secukinumab (SEC; COSENTYX(®), Novartis International AG, Basel, Switzerland) and certolizumab pegol (CZP; CIMZIA(®), UCB Pharma, Brussels, Belgium) have not previously been appraised by NICE...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28974896/access-to-biologicals-in-crohn-s-disease-in-ten-european-countries
#10
Márta Péntek, Peter L Lakatos, Talitha Oorsprong, László Gulácsi, Milena Pavlova, Wim Groot, Fanni Rencz, Valentin Brodszky, Petra Baji, Crohn's Disease Research Group
AIM: To analyze access (availability, affordability and acceptability) to biologicals for Crohn's disease (CD) in ten European countries and to explore the associations between these dimensions, the uptake of biologicals and economic development. METHODS: A questionnaire-based survey combined with desk research was carried out in May 2016. Gastroenterologists from the Czech Republic, France, Germany, Hungary, Latvia, Poland, Romania, Slovakia, Spain and Sweden were invited to participate and provide data on the availability of biologicals/biosimilars, reimbursement criteria, clinical practice and prices, and use of biologicals...
September 14, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28973005/a-systematic-review-of-cost-effectiveness-studies-comparing-conventional-biological-and-surgical-interventions-for-inflammatory-bowel-disease
#11
Nadia Pillai, Mark Dusheiko, Bernard Burnand, Valérie Pittet
BACKGROUND: Inflammatory bowel disease (IBD) is a chronic disease placing a large health and economic burden on health systems worldwide. The treatment landscape is complex with multiple strategies to induce and maintain remission while avoiding long-term complications. The extent to which rising treatment costs, due to expensive biologic agents, are offset by improved outcomes and fewer hospitalisations and surgeries needs to be evaluated. This systematic review aimed to assess the cost-effectiveness of treatment strategies for IBD...
2017: PloS One
https://www.readbyqxmd.com/read/28964446/market-exclusivity-time-for-top-selling-originator-drugs-in-canada-a-cohort-study
#12
Joel Lexchin
OBJECTIVES: This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated. METHODS: A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28961959/the-expanding-therapeutic-armamentarium-for-inflammatory-bowel-disease-how-to-choose-the-right-drug-s-for-our-patients
#13
Pieter Hindryckx, Niels Vande Casteele, Gregor Novak, Reena Khanna, Geert D'Haens, William J Sandborn, Silvio Danese, Vipul Jairath, Brian G Feagan
The therapeutic landscape for inflammatory bowel disease (IBD) is rapidly evolving. Two new biologic drugs, vedolizumab and ustekinumab, have recently entered the marketplace, the first biosimilars have been introduced, and several other agents are at an advanced stage of clinical development. In parallel, therapeutic goals have shifted from symptom control towards mucosal healing and prevention of bowel damage. In the coming years, gastroenterologists will be faced with unprecedented choices when selecting the best treatment for their patients with IBD...
August 25, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28955498/switching-from-originator-biological-agents-to-biosimilars-what-is-the-evidence-and-what-are-the-issues
#14
EDITORIAL
Eric Toussirot, Hubert Marotte
No abstract text is available yet for this article.
2017: RMD Open
https://www.readbyqxmd.com/read/28950806/the-in-use-stability-of-the-rituximab-biosimilar-rixathon%C3%A2-riximyo%C3%A2-upon-preparation-for-intravenous-infusion
#15
William C Lamanna, Katharina Heller, Daniel Schneider, Raffaele Guerrasio, Veronika Hampl, Cornelius Fritsch, Martin Schiestl
Purpose The purpose of this study was to evaluate the in-use physicochemical and biological stability of the Sandoz rituximab biosimilar, marketed under the trade names Rixathon® and Riximyo® in the European Union, upon preparation for intravenous infusion. Methods Three batches of Rixathon®/Riximyo® in the final month of their 36 month shelf life were exposed to room temperature and light for 14 days to recapitulate a major temperature excursion. Samples were diluted to the lowest allowable concentration of 1 mg/mL in 0...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28945143/cost-effectiveness-analysis-of-secukinumab-for-the-treatment-of-active-psoriatic-arthritis-a-canadian-perspective
#16
Ron Goeree, Sima Chiva-Razavi, Praveen Gunda, Christopher N Graham, LaStella Miles, Efthalia Nikoglou, Steffen M Jugl, Dafna Gladman
OBJECTIVE: The study evaluates the cost-effectiveness of secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, versus currently licensed biologic treatments in patients with active psoriatic arthritis (PsA) from a Canadian healthcare system perspective. METHODS: A decision analytic semi-Markov model evaluated the cost-effectiveness of secukinumab 150mg and 300mg compared to subcutaneous biologics adalimumab, certolizumab pegol, etanercept, golimumab, and ustekinumab and intravenous biologics infliximab and infliximab biosimilar in biologic-naive and biologic-experienced patients over a lifetime horizon...
September 25, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28935290/objectives-and-methodology-of-biobadaser-phase-iii
#17
Carlos Sanchez-Piedra, M Victoria Hernández Miguel, Javier Manero, Rosa Roselló, Jesús Tomás Sánchez-Costa, Carlos Rodríguez-Lozano, Cristina Campos, Eduardo Cuende, Jesús Carlos Fernández-Lopez, Sagrario Bustabad, Raquel Martín Domenech, Eva Pérez-Pampín, Javier Del Pino-Montes, Ana Milena Millan-Arcineas, Federico Díaz-González, Juan Jesús Gómez-Reino
OBJECTIVE: Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). METHODOLOGY: Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain...
September 18, 2017: Reumatología Clinica
https://www.readbyqxmd.com/read/28932268/therapeutic-drug-monitoring-of-ct-p13-a-comparison-of-four-different-immunoassays
#18
Joana Afonso, Helena Tavares de Sousa, Isadora Rosa, João Carvalho, Cláudia Camila Dias, Fernando Magro
BACKGROUND: The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX. METHODS: The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy...
September 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28929372/clinical-equivalence-with-g-csf-biosimilars-methodologic-approach-in-a-neo-adjuvant-setting-in-non-metastatic-breast-cancer
#19
REVIEW
A Krendyukov, M Schiestl, N Höbel, M Aapro
Biosimilars are biological medicines that have been shown to be similar to a reference biological medicine that has already been approved for use. Development of biosimilars is based on a "totality of evidence" approach that involves a series of steps by which biosimilars must demonstrate similarity to a reference product in all aspects of the drug and eliminate any remaining uncertainties. Clinical studies are then considered confirmatory and are performed to show that there are no clinically meaningful differences compared with the reference product in a sensitive patient population...
September 20, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28929342/perception-of-originator-biologics-and-biosimilars-a-survey-among-belgian-rheumatoid-arthritis-patients-and-rheumatologists
#20
Eline van Overbeeke, Birgit De Beleyr, Jan de Hoon, Rene Westhovens, Isabelle Huys
BACKGROUND: Among patients and rheumatologists, current knowledge and perception of biosimilars in comparison with originator biologics is unknown. OBJECTIVES: The aim of this study was to investigate this knowledge and perception in Belgian rheumatologists and rheumatoid arthritis (RA) patients. METHODS: Anonymous web surveys were conducted in Belgian RA patients (n = 121) and rheumatologists (n = 41) during the period January-March 2016...
September 19, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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