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Biosimilars

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https://www.readbyqxmd.com/read/29782806/analysis-of-sulfates-on-low-molecular-weight-heparin-using-mass-spectrometry-structural-characterization-of-enoxaparin
#1
Rohitesh Gupta, Moorthy P Ponnusamy
Structural characterization of Low Molecular Weight Heparin (LMWH) is critical to meet biosimilarity standards. In this context, the review focuses on structural analysis of labile sulfates attached to the side-groups of LMWH using mass spectrometry. A comprehensive review of this topic will help readers to identify key strategies for tackling the problem related to sulfate loss. At the same time, various mass spectrometry techniques are presented to facilitate compositional analysis of LMWH, mainly Enoxaparin...
May 21, 2018: Expert Review of Proteomics
https://www.readbyqxmd.com/read/29778525/mucus-penetrating-nanoparticles-promising-drug-delivery-systems-for-the-photodynamic-therapy-of-intestinal-cancer
#2
Juliane Anderski, Laura Mahlert, Dennis Mulac, Klaus Langer
Photodynamic therapy (PDT) is an auspicious therapy approach for the treatment of cancer. Despite its numerous benefits, the drug delivery of the used photosensitizer (PS) to target locations inside the human body remains a main therapy challenge, since the standard intravenous PS injection often causes systemic side-effects. To circumvent this therapy drawback, the oral application represents a promising administration alternative. Especially for the treatment of intestinal cancer it offers the possibility of a local treatment with a reduced likelihood for adverse drug reactions...
May 17, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29769386/global-acceptance-of-biosimilars-importance-of-regulatory-consistency-education-and-trust
#3
REVIEW
Eduardo Cazap, Ira Jacobs, Ali McBride, Robert Popovian, Karol Sikora
Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics...
May 16, 2018: Oncologist
https://www.readbyqxmd.com/read/29765782/biosimilars-have-arrived-rituximab
#4
REVIEW
Maria Greenwald, John Tesser, K Lea Sewell
A biosimilar is a biologic product that is highly similar to a licensed biologic ("originator") such that there are no clinically meaningful differences in safety, purity, or potency between the biosimilar and the originator. As patent protection and data exclusivity for the biologic rituximab expire, several potential biosimilars to rituximab are in development, which could soon lead to the availability of numerous rituximab biosimilars. Biosimilars are evaluated using thorough and rigorous analyses of the potential biosimilar versus the originator biological to confirm similar structure, function, and clinical efficacy as well as safety...
2018: Arthritis
https://www.readbyqxmd.com/read/29764238/successful-administration-of-bi-695501-an-adalimumab-biosimilar-using-an-autoinjector-ai-results-from-a-phase-ii-open-label-clinical-study-voltaire-%C3%A2-rl
#5
Stanley Cohen, Piotr A Klimiuk, Tillmann Krahnke, Deepak Assudani
BACKGROUND: This study examined the patient handling experience and self-injection success of patients with rheumatoid arthritis (RA) administering BI 695501 using an AI. METHODS: This Phase II, 7-week, open-label, interventional study (NCT02636907) included adult patients with moderately to severely active RA not adequately controlled by DMARDs, with no experience of self-injecting with AI/pen. Patients self-injected BI 695501 via AI every 2 weeks in the AI Assessment Period (AAP)...
May 15, 2018: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29757040/cost-savings-for-biosimilars-in-the-united-states-a-theoretical-framework-and-budget-impact-case-study-application-using-filgrastim
#6
Simrun Grewal, Scott Ramsey, Sanjeev Balu, Josh J Carlson
OBJECTIVE: Biosimilars can directly reduce the cost of treating patients for whom a reference biologic is indicated by offering a highly similar, lower priced alternative. We examine factors related to biosimilar regulatory approval, uptake, pricing, and financing and the potential impact on drug expenditures in the U.S. METHODS: We developed a framework to illustrate how key factors including regulatory policies, provider and patient perception, pricing, and payer policies impact biosimilar cost-savings...
May 14, 2018: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/29756565/anti-tnf-biosimilars-in-inflammatory-bowel-disease-searching-the-proper-patient-s-profile
#7
Silvio Danese, Gionata Fiorino
Biosimilars of infliximab (CT-P13) are currently approved and available for the same indications as the originator. Some concerns about safety and immunogenicity have risen in the past because of lack of data in IBD. Since 2015, several cohort studies have been conducted in IBD showing that CT-P13 has comparable safety and efficacy profile to the originator, both in adult and pediatric population, either in naïve patients, or even in those who switched from the originator to CT-P13. This review aims to analyze the current literature data in order to define a clear patient profile, to identify those IBD patients who would benefit the most from the use of CT-P13...
May 13, 2018: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/29753532/switching-from-an-originator-anti-tnf-to-a-biosimilar-in-patients-with-inflammatory-bowel-disease-can-it-be-recommended-a-systematic-review
#8
Javier P Gisbert, María Chaparro
AIM: To review the effectiveness and safety of switching from an originator anti-TNF (Remicade® ) to a biosimilar (CT-P13) in patients with inflammatory bowel disease (IBD). METHODS: Electronic and manual search up to September 2017. RESULTS: We identified 24 studies evaluating switching between Remicade® and CT-P13 in 1326 patients. Disease control (no worsening after switching) was confirmed in most of the patients (weighted mean, 88%; 95% CI=86-89%)...
May 9, 2018: Gastroenterología y Hepatología
https://www.readbyqxmd.com/read/29753369/biosimilars-for-immune-mediated-chronic-diseases-in-primary-care-what-a-practicing-physician-needs-to-know
#9
REVIEW
Steven R Feldman, Jerry Bagel, Shahla Namak
The introduction of biologics has revolutionized the treatment of immune-mediated diseases, but high cost and limited patient access remain hurdles, and some physicians are concerned that biosimilars are not similar enough. The purpose of this narrative review is to describe biosimilar safety, efficacy, nomenclature, extrapolation and interchangeability. In the United States, the Biologics Price Competition and Innovation Act created an abbreviated pathway for licensing of a biologic that is biosimilar to another licensed product (i...
May 2018: American Journal of the Medical Sciences
https://www.readbyqxmd.com/read/29751008/impact-of-glycosylation-on-the-local-backbone-flexibility-of-well-defined-igg1-fc-glycoforms-using-hydrogen-exchange-mass-spectrometry-hx-ms
#10
Apurva S More, Ronald T Toth, Solomon Z Okbazghi, C Russell Middaugh, Sangeeta B Joshi, Thomas J Tolbert, David B Volkin, David D Weis
We have utilized hydrogen exchange-mass spectrometry (HX-MS) to characterize local backbone flexibility of four well-defined IgG1-Fc glycoforms expressed and purified from Pichia pastoris, two of which were prepared using subsequent in vitro enzymatic treatments. Progressively decreasing the size of the N-linked N297 oligosaccharide from high mannose (Man8-Man12), to Man5, to GlcNAc, to non-glycosylated N297Q resulted in progressive increases in backbone flexibility. Comparison of these results with recently published physicochemical stability and Fcγ receptor binding data with the same set of glycoproteins provide improved insights into correlations between glycan structure and these pharmaceutical properties...
May 8, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29748754/rational-selection-criticality-assessment-and-tiering-of-quality-attributes-and-test-methods-for-analytical-similarity-evaluation-of-biosimilars
#11
Kristof Vandekerckhove, Andreas Seidl, Hiten Gutka, Manish Kumar, Gyöngyi Gratzl, David Keire, Todd Coffey, Henriette Kuehne
Leading regulatory agencies recommend biosimilar assessment to proceed in a stepwise fashion, starting with a detailed analytical comparison of the structural and functional properties of the proposed biosimilar and reference product. The degree of analytical similarity determines the degree of residual uncertainty that must be addressed through downstream in vivo studies. Substantive evidence of similarity from comprehensive analytical testing may justify a targeted clinical development plan, and thus enable a shorter path to licensing...
May 10, 2018: AAPS Journal
https://www.readbyqxmd.com/read/29747243/biosimilars
#12
J Barker
Biologics have had an enormous impact on the practice of medicine. In cancer, checkpoint inhibitors have dramatically improved survival, including in melanoma. In chronic inflammatory diseases their impact has been similarly impressive. To date in dermatology this has mainly been felt in the management of severe psoriasis. This article is protected by copyright. All rights reserved.
May 10, 2018: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/29743182/fda-s-approval-of-the-first-biosimilar-to-bevacizumab
#13
Sandra J Casak, Steven J Lemery, Jee Chung, Chana Fuchs, Sarah J Schrieber, Edwin C Y Chow, Weishi Yuan, Lisa Rodriguez, Thomas Gwise, Anne Rowzee, Sue Lim, Patricia Keegan, Amy E McKee, Richard Pazdur
Passage of the Biologics Price Competition and Innovation Act of 2009 created an abbreviated licensure pathway for biosimilar products. The Food and Drug Administration approved ABP215 (MVASI, bevacizumab-awwb, Amgen) as a biosimilar to US-licensed Avastin (bevacizumab, Genentech) based on an extensive comparative analytical characterization, data obtained in a pharmacokinetic similarity study in healthy subjects, and a comparative clinical study in patients with non-small cell lung cancer. The totality of the evidence for biosimilarity supported extrapolation of the data to support licensure as a biosimilar for other approved indications of US-licensed Avastin, without the need of additional clinical studies...
May 9, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29741753/a-tale-of-two-antibodies-obinutuzumab-versus-rituximab
#14
REVIEW
Ciara L Freeman, Laurie H Sehn
While rituximab has dramatically improved outcomes for patients with CD20+ malignancies for two decades, responses are not universal and resistance can develop. Obinutuzumab was developed to potentiate activity and overcome resistance. Pre-clinical data suggests obinutuzumab is superior to rituximab at effecting B cell depletion; however recent phase III clinical trial results have been mixed. The decision of which antibody to employ will probably be further complicated by the approval of a subcutaneous preparation of rituximab and several anti-CD20 biosimilars...
May 9, 2018: British Journal of Haematology
https://www.readbyqxmd.com/read/29739669/bullying-biosimilars-cheaper-drugs-stymied-in-usa
#15
EDITORIAL
The Lancet Gastroenterology Hepatology
No abstract text is available yet for this article.
June 2018: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29732144/evaluation-of-the-physicochemical-and-biological-stability-of-reconstituted-and-diluted-sb2-infliximab
#16
Jihyun Kim, Jihyun Chung, Sujin Park, Saem Jung, Dukwon Kang
Objectives: To evaluate the critical quality attributes that might affect the stability of an infliximab biosimilar (SB2, Flixabi) when reconstituted or diluted and stored under refrigeration and at room temperature. Methods: We largely adhered to the UK's National Health Service guidance requirements for the design of a robust stability study and for robust testing methods. Protocol components included evaluation of visual appearance, chemical stability, physical stability, pH, particle sizes and biological activity...
May 2018: European Journal of Hospital Pharmacy. Science and Practice
https://www.readbyqxmd.com/read/29731461/-diagnosis-and-treatment-of-rheumatoid-arthritis-toward-the-best-practice-the-best-practice-for-tnf-inhibitors
#17
Hideto Kameda
As of February 2018, 5 originator TNF inhibitors(infliximab, etanercept, adalimumab, golimumab and certolizumab pegol)and biosimilar agents of infliximab and etanercept are available for rheumatoid arthritis(RA)in Japan. The effectiveness of TNF inhibitors considerably improves with concomitant methotrexate regardless of their immunogenicity. The Japan College of Rheumatology guideline for TNF inhibitor use in RA has been updated in March 2017 according to recent evidences. During the remission induction phase, maintenance of drug trough level above effective blood concentration is paramount, while the tapering and withdrawal of TNF inhibitors may be considered after achieving sustained remission...
2018: Clinical Calcium
https://www.readbyqxmd.com/read/29714562/fda-expectations-for-demonstrating-interchangeability
#18
Kamali Chance
There is a great interest from global companies who are developing biosimilars to pursue interchangeability designation for commercialization of their products in the US. An interchangeability designation will not only allow the substitutability at the pharmacy level without the intervention of a health care provider but the first sponsor who is able to garner interchangeability designation will also receive 12 months of marketing exclusivity. This paper will highlight our current understanding of FDA expectations with regards to demonstrating interchangeability...
May 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29714020/epitope-binning-of-human-monoclonal-antibodies-in-classical-sandwich-and-in-tandem-orientation-using-the-octet-system-based-on-biolayer-interferometry
#19
Lisette Bronswijk-Deddens
Epitope binning is a technique used to cluster different monoclonal antibodies by the specific region on the antigen that is recognized by the antibody. This is used to increase the likelihood of choosing lead antibodies with the desired biological activity by selecting antibodies from distinct bins, to confirm that biosimilars or biobetters bind to similar epitopes and to select reagents for diagnostic sandwich and/or ELISA-type assays. This protocol describes epitope binning of seven human monoclonal antibodies to a monovalent antigen in two orthogonal orientations; a classical sandwich and an in-tandem orientation using an eight-channel Octet system...
2018: Methods in Molecular Biology
https://www.readbyqxmd.com/read/29713519/a-highly-productive-cho-cell-line-secreting-human-blood-clotting-factor-ix
#20
S V Kovnir, N A Orlova, M I Shakhparonov, K G Skryabin, A G Gabibov, I I Vorobiev
Hemophilia B patients suffer from an inherited blood-clotting defect and require regular administration of blood-clotting factor IX replacement therapy. Recombinant human factor IX produced in cultured CHO cells is nearly identical to natural, plasma-derived factor IX and is widely used in clinical practice. Development of a biosimilar recombinant human factor IX for medical applications requires the generation of a clonal cell line with the highest specific productivity possible and a high level of specific procoagulant activity of the secreted factor IX...
January 2018: Acta Naturae
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