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https://www.readbyqxmd.com/read/29123576/the-efficacy-and-safety-of-the-biosimilar-product-inflectra-%C3%A2-compared-to-the-reference-drug-remicade-%C3%A2-in-rescue-therapy-in-adult-patients-with-ulcerative-colitis
#1
Magdalena Kaniewska, Andrzej Moniuszko, Grażyna Rydzewska
Introduction: The biosimilar product Inflectra(®) has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC). Aim: To assess the efficacy and safety of the biosimilar product Inflectra(®) in comparison with its reference biological agent (Remicade(®)) in rescue therapy in adult patients presenting with severe exacerbation of UC, as well as to evaluate recurrence rate during a 6-month observation after finish of treatment...
2017: Przegla̜d Gastroenterologiczny
https://www.readbyqxmd.com/read/28903543/biosimilars-in-rheumatology-a-review-of-the-evidence-and-their-place-in-the-treatment-algorithm
#2
REVIEW
Hendrik Schulze-Koops, Alla Skapenko
Determining biosimilarity involves a comprehensive exercise with a focus on determining the comparability of the molecular characteristics and preclinical profile of the biosimilar and reference product, such that there is less need for extensive clinical testing to assure comparability of clinical outcomes. Three anti-TNF biosimilar agents are approved for patients with rheumatic diseases in the European Union. The infliximab (Remicade®) biosimilars CT-P13 (Remsima® and Inflectra®) and SB2 (Flixabi®) and the etanercept (Enbrel®) biosimilar SB4 (Benepali®) have shown close comparability to their reference medicinal products, having undergone extensive evaluations...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28640663/glycosylation-profile-and-biological-activity-of-remicade%C3%A2-compared-with-flixabi%C3%A2-and-remsima%C3%A2
#3
Changsoo Lee, Min Jeong, JongAh Joanne Lee, Saebom Seo, Sung Chun Cho, Wei Zhang, Orlando Jaquez
As biosimilars enter the market, comparisons of product quality are needed. Manufacturing differences may lead to differences in critical quality attributes, which affect efficacy. Therefore, critical quality attributes (structure and biological activity) of Remicade® and of 2 biosimilar products (Flixabi®/Renflexis® and Remsima®/Inflectra®) were determined. We assessed binding to tumor necrosis factor in a fluorescence competitive binding assay; potency in a luciferase reporter gene assay; percentages of galactosylated glycan, afucose plus high mannosylated glycans, and charged glycan; FcγRIIIa (CD16) binding (assessed by 3 methods); and antibody-dependent cell-mediated cytotoxicity (ADCC) in the NK92-CD16a cell line and in peripheral blood mononuclear cells (PBMC)...
August 2017: MAbs
https://www.readbyqxmd.com/read/28593609/therapeutic-drug-monitoring-tdm-as-a-tool-in-the-switch-from-infliximab-innovator-to-biosimilar-in-rheumatic-patients-results-of-a-12-month-observational-prospective-cohort-study
#4
E M H Schmitz, S Benoy-De Keuster, A J L Meier, V Scharnhorst, R A M Traksel, M A C Broeren, L J J Derijks
The objective of this study is to apply therapeutic drug monitoring (TDM) as an objective tool to monitor the switch from infliximab innovator (INX) to infliximab biosimilar (INB) in our diverse rheumatic cohort in daily clinical practice. All rheumatic patients on INX treatment (Remicade®) and ≥18 years were switched to INB (Inflectra®) as part of routine care, but in a controlled setting. Patients were monitored by taking blood samples just before the first infusion of INB (T1), and after the second (T2), fourth (T3), and seventh (T4) infusion of INB...
June 7, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28444254/the-effect-of-biosimilars-inflectra%C3%A2-in-the-management-of-acute-severe-ulcerative-colitis
#5
Grace Harkin, Áine Keogh, Eoin Slattery
No abstract text is available yet for this article.
October 27, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28365979/a-multidimensional-analytical-comparison-of-remicade-and-the-biosimilar-remsima
#6
Karthik Pisupati, Yuwei Tian, Solomon Okbazghi, Alexander Benet, Rose Ackermann, Michael Ford, Sergei Saveliev, Christopher M Hosfield, Marjeta Urh, Eric Carlson, Christopher Becker, Thomas J Tolbert, Steven P Schwendeman, Brandon T Ruotolo, Anna Schwendeman
In April 2016, the Food and Drug Administration approved the first biosimilar monoclonal antibody (mAb), Inflectra/Remsima (Celltrion), based off the original product Remicade (infliximab, Janssen). Biosimilars promise significant cost savings for patients, but the unavoidable differences between innovator and copycat biologics raise questions regarding product interchangeability. In this study, Remicade and Remsima were examined by native mass spectrometry, ion mobility, and quantitative peptide mapping. The levels of oxidation, deamidation, and mutation of individual amino acids were remarkably similar...
May 2, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28208257/hydrophilic-interaction-chromatography-hyphenated-with-mass-spectrometry-a-powerful-analytical-tool-for-the-comparison-of-originator-and-biosimilar-therapeutic-monoclonal-antibodies-at-the-middle-up-level-of-analysis
#7
Valentina D'Atri, Szabolcs Fekete, Alain Beck, Matthew Lauber, Davy Guillarme
The development and approval processes of biosimilar mAbs depend on their comparability to originators. Therefore, analytical comparisons are required to assess structural features and post-translational modifications (PTM) and thereby minimize the risk of being clinically meaningful differences between biosimilar and originator drug products. The glycosylation pattern of mAbs is considered to be an important critical quality attribute (CQA), and several analytical approaches have been proposed that facilitate characterizing and monitoring a glycosylation profile, albeit mainly at a glycan and glycopeptide level of analysis...
February 7, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28175207/p632-comparative-analysis-of-the-pharmacokinetics-of-inflectra%C3%A2-biosimilar-with-remicade%C3%A2-in-the-induction-phase-of-remission-in-patients-with-crohn-s-disease
#8
G Juan, M Mora, A Alvariño, N Maroto, I Ferrer, E Hinojosa, M D Hinojosa, P Ferrandis, J Hinojosa
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28147370/does-the-introduction-of-biosimilars-change-our-understanding-about-treatment-modalities-for-inflammatory-bowel-disease
#9
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/28118651/inflectra-an-infliximab-biosimilar
#10
REVIEW
(no author information available yet)
No abstract text is available yet for this article.
January 30, 2017: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/28056484/-biosimilars-in-inflammatory-bowel-disease-ibd-experiences-and-perceptions-of-german-gastroenterologists
#11
Bernd Bokemeyer, Axel Dignaß, Stefan Schreiber
The European Medicines Agency (EMA) recently approved the first anti-TNF-alpha biosimilar for infliximab (CT-P13) (trade names: Inflectra(®) and Remsima(®)) in Germany. Over the past year, German gastroenterologists gained experience treating IBD-patients with infliximab biosimilars (IFX-biosimilars). To evaluate their experiences and opinions on biosimilars, we conducted a nationwide online survey among German gastroenterologists. Our results are based on the assessment of 449 questionnaires. Although 61 % of the participants had already prescribed IFX-biosimilars, about two thirds of these participating gastroenterologists with IFX-biosimilar prescription stated their experience as based on fewer than 10 IBD-patients treated with IFX-biosimilars...
April 2017: Zeitschrift Für Gastroenterologie
https://www.readbyqxmd.com/read/27971502/clinical-and-economic-impact-of-the-use-of-infliximab-biosimilar-inflectra-in-rheumatoid-arthritis-psoriatic-arthropathy-and-ankylosing-spondylitis-patients
#12
J Borras Blasco, A Gracia-Pérez, D Casterá, D Rosique-Robles, J Abad, H Heskouri Benlemlih
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27971472/a-cost-effectiveness-analysis-of-biosimilar-infliximab-inflectra%C3%A2-for-the-treatment-of-psoriatic-arthritis-in-nine-european-countries
#13
F Rencz, Brodszky, M Péntek, L Gulacsi, P Baji
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27971471/a-cost-effectiveness-analysis-of-biosimilar-infliximab-inflectra-%C3%A2-for-the-treatment-of-ankylosing-spondylitis-in-nine-european-countries
#14
F Rencz, Brodszky, M Péntek, L Gulacsi, P Baji
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27650650/infliximab-biosimilar-ct-p13-infliximab-dyyb-a-review-in-autoimmune-inflammatory-diseases
#15
REVIEW
Hannah A Blair, Emma D Deeks
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima(®), Inflectra(®)) is approved in several countries for use in all indications for which reference infliximab (Remicade(®)) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27564646/a-critical-review-of-biosimilars-in-ibd-the-confluence-of-biologic-drug-development-regulatory-requirements-clinical-outcomes-and-big-business
#16
Christina Y Ha, Asher Kornbluth
On February 9, 2016, the Food and Drug Administration Arthritis Advisory Committee recommended by a vote of 21 to 3, that the biosimilar to infliximab, CT-P13, be approved for rheumatoid arthritis and ankylosing spondylitis and, by extrapolation, for all the indications for which infliximab is currently approved, including adult and pediatric ulcerative colitis and Crohn's disease. On April 5, 2016, the Food and Drug Administration concurred with this recommendation and approved CT-P13 (Inflectra; Pfizer Inc...
October 2016: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/27435444/ct-p13-inflectra%C3%A2-remsima%C3%A2-monitoring-in-patients-with-inflammatory-bowel-disease
#17
Kornelius Schulze, Nadine Koppka, Frederik Lutter, Gunnar Brandhorst, Stefan Schreiber, Ulf Helwig
The approval of infliximab biosimilars Remsima™ and Inflectra™ (CT-P13) for patients with inflammatory bowel disease (IBD) is a promising step to reduce treatment costs. Since monitoring of Remicade™ serum trough levels and anti-Remicade™ immunogenicity hold an important significance in treatment modalities, no data about monitoring of drug serum trough levels or anti-drug antibody levels in IBD patients treated with Remsima™ or Inflectra™ are present to date. Therefore, in this study we applied a Remicade™-validated ELISA to determine drug serum levels of Remsima™ or Inflectra™...
September 2016: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/27408516/pharmaceutical-approval-update
#18
Mary Choy
Defibrotide sodium (Defitelio) for hepatic veno-occlusive disease; emtricitabine/tenofovir alafenamide (Descovy) for human immunodeficiency virus infection; and infliximabdyyb (Inflectra) for Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
July 2016: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/27260215/advanced-assessment-of-the-physicochemical-characteristics-of-remicade%C3%A2-and-inflectra%C3%A2-by-sensitive-lc-ms-techniques
#19
Jing Fang, Catalin Doneanu, William R Alley, Ying Qing Yu, Alain Beck, Weibin Chen
In this study, we demonstrate the utility of ultra-performance liquid chromatography coupled to mass spectrometry (MS) and ion-mobility spectrometry (IMS) to characterize and compare reference and biosimilar monoclonal antibodies (mAbs) at an advanced level. Specifically, we focus on infliximab and compared the glycan profiles, higher order structures, and their host cell proteins (HCPs) of the reference and biosimilar products, which have the brand names Remicade® and Inflectra®, respectively. Overall, the biosimilar attributes mirrored those of the reference product to a very high degree...
August 2016: MAbs
https://www.readbyqxmd.com/read/27130908/efficacy-and-safety-of-ct-p13-biosimilar-infliximab-in-patients-with-rheumatoid-arthritis-comparison-between-switching-from-reference-infliximab-to-ct-p13-and-continuing-ct-p13-in-the-planetra-extension-study
#20
RANDOMIZED CONTROLLED TRIAL
Dae Hyun Yoo, Nenad Prodanovic, Janusz Jaworski, Pedro Miranda, Edgar Ramiterre, Allan Lanzon, Asta Baranauskaite, Piotr Wiland, Carlos Abud-Mendoza, Boycho Oparanov, Svitlana Smiyan, HoUng Kim, Sang Joon Lee, SuYeon Kim, Won Park
OBJECTIVES: To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions. METHODS: This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102...
February 2017: Annals of the Rheumatic Diseases
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