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https://www.readbyqxmd.com/read/28526943/a-global-reference-comparator-for-biosimilar-development
#1
Christopher J Webster, Gillian R Woollett
Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them licensed locally. The costs of these studies are not trivial in absolute terms and, due to the multiplier effect of required repetition by each biosimilar sponsor, their collective costs are substantial. Yet versions of biologics licensed in different jurisdictions usually share the same development data, and any manufacturing changes between versions have been justified by a rigorous comparability process...
May 19, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28526658/nonclinical-pharmacology-and-toxicology-of-the-first-biosimilar-insulin-glargine-drug-product-basaglar-%C3%A2-abasaglar-%C3%A2-approved-in-the-european-union
#2
Richard A Byrd, Rebecca A Owens, Jamie L Blackbourne, David E Coutant, Mark W Farmen, M Dodson Michael, Julie S Moyers, A Eric Schultze, Michael K Sievert, Niraj K Tripathi, John L Vahle
Basaglar(®)/Abasaglar(®) (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus(®) (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity...
May 16, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28523951/launching-biosimilar-rituximab-an-industry-opinion-on-biosimilar-uptake-in-europe
#3
Richard Trollope, Sue Johnson, Henry Ireland
Richard Trollope and Sue Johnson talk with Henry Ireland, Senior Editor about the recent approval of biosimilar rituximab (Truxima(®)) & the current state of biosimilar uptake across Europe Richard Trollope, Head of Biosimilars, Mundipharma International Limited, qualified as a biochemist before joining Wyeth's commercial operations, prior to its acquisition by Pfizer. Richard later joined Yamanouchi Pharmaceuticals (now Astellas Pharma). His fascination with oncology led him to join Mundipharma in Europe and after joining the company's UK arm (Napp Pharmaceuticals Limited), Richard began his journey in biosimilars...
May 19, 2017: Immunotherapy
https://www.readbyqxmd.com/read/28518088/in-vitro-methods-for-comparing-target-binding-and-cdc-induction-between-therapeutic-antibodies-applications-in-biosimilarity-analysis
#4
Nohemi Salinas-Jazmín, Edith González-González, Luz X Vásquez-Bochm, Sonia M Pérez-Tapia, Marco A Velasco-Velázquez
Therapeutic monoclonal antibodies (mAbs) are relevant to the treatment of different pathologies, including cancers. The development of biosimilar mAbs by pharmaceutical companies is a market opportunity, but it is also a strategy to increase drug accessibility and reduce therapy-associated costs. The protocols detailed here describe the evaluation of target binding and CDC induction by rituximab in Daudi cells. These two functions require different structural regions of the antibody and are relevant to the clinical effect induced by rituximab...
May 4, 2017: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/28516439/reassessment-of-anti-cd20-therapy-in-lymphoid-malignancies-impact-limitations-and-new-directions
#5
REVIEW
Patrick M Reagan, Jonathan W Friedberg
The addition of anti-CD20 monoclonal antibodies to the treatment of B-cell malignancies has dramatically affected the field as well as the lives of patients. Rituximab in particular has been combined safely with conventional chemotherapy and has resulted in improved overall survival in major histologic subtypes of B-cell lymphoma and chronic lymphocytic leukemia. It is incorporated into the standard initial treatment of nearly all of these diseases. Novel anti-CD20 antibodies are currently under development...
May 15, 2017: Oncology (Williston Park, NY)
https://www.readbyqxmd.com/read/28513438/improving-access-to-biosimilars-in-low-income-countries
#6
EDITORIAL
The Lancet
No abstract text is available yet for this article.
May 13, 2017: Lancet
https://www.readbyqxmd.com/read/28510523/new-solutions-for-curbing-runaway-drug-costs
#7
Zachary Hafner
Long at odds, the interests of payers and providers are becoming more compatible and aligned. Both stakeholders need to collaborate to manage costs. Encouraging use of generics and biosimilars is one way they can slow down the soaring drug spend.
March 2017: Managed Care
https://www.readbyqxmd.com/read/28510522/managed-care-reader-poll-readers-believe-biosimilars-will-be-effective-against-costs
#8
(no author information available yet)
In an online survey of readers conducted in late January and early February, 20% of the 113 respondents indicated that they believed that biosimilars will be highly effective in lowering drug costs, and the reader ratings of their effectiveness skewed toward positive.
March 2017: Managed Care
https://www.readbyqxmd.com/read/28510518/biosimilar-makers-hope-court-starts-6-month-wait-sooner
#9
Ed Silverman
The dispute centers on dueling interpretations of the Biologics Price Competition and Innovation Act, which says a company seeking to sell a biosimilar must give the maker of the brand-name biologic at least a 180-day notice before selling its drug.
March 2017: Managed Care
https://www.readbyqxmd.com/read/28510517/biosimilars-in-oncology-reality-could-bite-the-copycats-dog-potential-major-savings
#10
Timothy Kelley
No one knows how much of an effect biosimilars will have on oncology expenditures. Pricing and market share are in a large, opaque "to be determined" cloud. But there's certainly potential for a major impact that could lower oncology expenditures by millions, if not billions.
March 2017: Managed Care
https://www.readbyqxmd.com/read/28510516/the-biosimilar-pipeline-seams-seem-to-be-bursting
#11
Thomas Reinke
The biosimilar segment of the pharmaceutical industry is on fire. Some 700 biosimilars are at some stage of development, and more than 660 companies are involved in some way in the biosimilars land rush. Still, only a handful may get on the market in the next few years.
March 2017: Managed Care
https://www.readbyqxmd.com/read/28510515/biosimilars-ready-at-last-to-make-their-entrance-stars-are-born-or-do-they-fizzle
#12
Thomas Reinke
The future of biosimilars in this country is nothing if not uncertain. Most immediately, the U.S. Supreme Court is hearing a case that will determine the timing of the 180-day waiting period before a biosimilar can go on the market. But there are larger and longer-term issues at play as well.
March 2017: Managed Care
https://www.readbyqxmd.com/read/28509534/analysis-of-three-epoetin-alpha-products-by-lc-and-lc-ms-indicates-differences-in-glycosylation-critical-quality-attributes-including-sialic-acid-content
#13
Rebecca I Thomson, Richard Andrew Gardner, Katja Strohfeldt, Daryl L Fernandes, Graham Philip Stafford, Daniel I R Spencer, Helen M I Osborn
Erythropoietin (EPO) is one of the main treatments for anaemic patients, greatly improving their quality of life. In this study, biosimilars Binocrit and a development product, called here CIGB-EPO, were compared to the originator product, Eprex. All three are epoetin alpha products, reputed to have similar glycosylation profiles. The quality, safety and efficacy of this biotherapeutic depend on the following glycosylation critical quality attributes (GCQAs): sialylation, N-glycolyl-neuraminic acid (Neu5Gc) content, branching, N-acetyl-lactosamine (LacNAc) extensions and, arguably, O-acetylation pattern...
May 16, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28504555/frequency-and-characteristics-of-infusion-reactions-during-biosimilar-infliximab-treatment-in-inflammatory-bowel-diseases-results-from-central-european-nationwide-cohort
#14
Anita Bálint, Mariann Rutka, Zsuzsanna Végh, Zsuzsanna Kürti, Krisztina B Gecse, János Banai, László Bene, Beáta Gasztonyi, Tünde Kristóf, László Lakatos, Pál Miheller, Károly Palatka, Árpád Patai, Ágnes Salamon, Tamás Szamosi, Zoltán Szepes, Gábor Tamás Tóth, Áron Vincze, Renáta Bor, Ágnes Milassin, Anna Fábián, Ferenc Nagy, Martin Kolar, Martin Bortlik, Dana Duricova, Veronika Hruba, Martin Lukas, Katarina Mitrova, Karin Malickova, Milan Lukas, Péter L Lakatos, Tamás Molnár, Klaudia Farkas
INTRODUCTION: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. METHODS: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically...
May 15, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28502609/switching-from-originator-infliximab-to-biosimilar-ct-p13-compared-with-maintained-treatment-with-originator-infliximab-nor-switch-a-52-week-randomised-double-blind-non-inferiority-trial
#15
Kristin K Jørgensen, Inge C Olsen, Guro L Goll, Merete Lorentzen, Nils Bolstad, Espen A Haavardsholm, Knut E A Lundin, Cato Mørk, Jørgen Jahnsen, Tore K Kvien
BACKGROUND: TNF inhibitors have improved treatment of Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, but are expensive therapies. The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy, safety, and immunogenicity. METHODS: The study is a randomised, non-inferiority, double-blind, phase 4 trial with 52 weeks of follow-up...
May 11, 2017: Lancet
https://www.readbyqxmd.com/read/28502608/the-switch-to-infliximab-biosimilars
#16
Richard Veselý, Peter Richardson
No abstract text is available yet for this article.
May 11, 2017: Lancet
https://www.readbyqxmd.com/read/28497221/evaluation-of-the-cross-reactivity-of-antidrug-antibodies-to-ct-p13-and-infliximab-reference-product-remicade-an-analysis-using-immunoassays-tagged-with-both-agents
#17
Walter Reinisch, Jørgen Jahnsen, Stefan Schreiber, Silvio Danese, Julián Panés, Alejandro Balsa, Won Park, JiSoo Kim, Jee Un Lee, Dae Hyun Yoo
BACKGROUND: During two pivotal clinical trials of the infliximab biosimilar CT-P13 (PLANETAS and PLANETRA), antidrug antibodies (ADAs) and neutralising antibodies (NAbs) were detected in the sera of patients treated with CT-P13 and the reference product (RP; Remicade). OBJECTIVE: The aim was to assess the comparability of Remicade- and CT-P13-tagged immunoassays for the detection of ADAs and NAbs using data from these trials, in order to determine the cross-reactivity of CT-P13 and RP ADAs...
May 11, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28497220/ct-p10-truxima%C3%A2-a-rituximab-biosimilar
#18
Emma D Deeks
CT-P10 (Truxima™) is the first biosimilar of the reference monoclonal anti-CD20 antibody rituximab. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. CT-P10 has similar physicochemical and pharmacodynamic properties to those of reference rituximab, and the pharmacokinetic biosimilarity of the agents has been shown in patients with RA or FL...
May 11, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28496277/a-framework-for-integrating-biosimilars-into-the-didactic-core-requirements-of-a-doctor-of-pharmacy-curriculum
#19
REVIEW
Edward Li, Jennifer Liu, Monica Ramchandani
Biologic drugs approved via the abbreviated United States biosimilar approval pathway are anticipated to improve access to medications by addressing increasing health care expenditures. Surveys of health care practitioners indicate that there is inadequate knowledge and understanding about biosimilars; this must be addressed to ensure safe and effective use of this new category of products. Concepts of biosimilar development, manufacturing, regulation, naming, formulary, and inventory considerations, as well as patient and provider education should be included within the doctor of pharmacy (PharmD) curriculum as preparation for clinical practice...
April 2017: American Journal of Pharmaceutical Education
https://www.readbyqxmd.com/read/28495312/considerations-of-critical-quality-attributes-in-the-analytical-comparability-assessment-of-biosimilar-products
#20
Ohseok Kwon, Jeewon Joung, Younjoo Park, Chan Wha Kim, Seung Hwa Hong
Based on experience in clinical trial approvals and marketing authorizations for biosimilar products in Korea, we suggest principles for the analytical comparability assessment of biosimilar products with respect to regulatory considerations. The composition and manufacturing processes of biosimilar products can differ from those of the reference product depending on the information available for the reference product and the time of product development; however, the analytical characteristics of biosimilar products should be highly similar to those of the reference product...
May 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
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