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Biosimilars

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https://www.readbyqxmd.com/read/28929372/clinical-equivalence-with-g-csf-biosimilars-methodologic-approach-in-a-neo-adjuvant-setting-in-non-metastatic-breast-cancer
#1
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
#2
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
https://www.readbyqxmd.com/read/28927246/biosimilar-ct-p13-in-treating-ulcerative-colitis-in-the-real-world
#3
Davide G Ribaldone, Marco Astegiano
No abstract text is available yet for this article.
December 2017: Minerva Gastroenterologica e Dietologica
https://www.readbyqxmd.com/read/28922253/long-term-efficacy-safety-and-immunogenicity-of-biosimilar-infliximab-after-one-year-in-a-prospective-nationwide-cohort
#4
Lorant Gonczi, Krisztina B Gecse, Zsuzsanna Vegh, Zsuzsanna Kurti, Mariann Rutka, Klaudia Farkas, Petra A Golovics, Barbara D Lovasz, Janos Banai, Laszlo Bene, Bea Gasztonyi, Tunde Kristof, Laszlo Lakatos, Pal Miheller, Ferenc Nagy, Karoly Palatka, Maria Papp, Arpad Patai, Agnes Salamon, Tamas Szamosi, Zoltan Szepes, Gabor T Toth, Aron Vincze, Balazs Szalay, Tamas Molnar, Peter L Lakatos
BACKGROUND: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. METHODS: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC)...
August 23, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28921160/gp2013-a-rituximab-biosimilar
#5
Hannah A Blair
GP2013 is the second biosimilar of the reference monoclonal anti-CD20 antibody rituximab to be approved in the EU. 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. GP2013 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...
September 18, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28920454/investigation-of-o-glycosylation-heterogeneity-of-recombinant-coagulation-factor-ix-using-lc-ms-ms
#6
Youngsuk Seo, Gyeong Mi Park, Myung Jin Oh, Hyun Joo An
AIM: Recombinant coagulation factor IX (rFIX) has extraordinarily multiple post-translational modifications including N-glycosylation and O-glycosylation which have a drastic effect on biological functions and in vivo recovery. Unlike N-glycosylation extensively characterized, there are a few studies on O-glycosylation due to its intrinsic complexity. In-depth O-glycosylation analysis is necessary to better understand and assess pharmacological activity of rFIX. RESULTS: We determined unusual O-glycosylations including O-fucosylation and O-glucosylation which were located at Serine 53 and 61, respectively in EGF domain...
September 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28920453/sensitive-and-comprehensive-analysis-of-o-glycosylation-in-biotherapeutics-a-case-study-of-novel-erythropoiesis-stimulating-protein
#7
Unyong Kim, Myung Jin Oh, Youngsuk Seo, Yinae Jeon, Joon-Ho Eom, Hyun Joo An
AIM: Glycosylation of recombinant human erythropoietins (rhEPOs) is significantly associated with drug's quality and potency. Thus, comprehensive characterization of glycosylation is vital to assess the biotherapeutic quality and establish the equivalency of biosimilar rhEPOs. However, current glycan analysis mainly focuses on the N-glycans due to the absence of analytical tools to liberate O-glycans with high sensitivity. We developed selective and sensitive method to profile native O-glycans on rhEPOs...
September 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28920451/demonstrating-biosimilar-and-originator-antidrug-antibody-binding-comparability-in-antidrug-antibody-assays-a-practical-approach
#8
Janka Ryding, Michael Stahl, Martin Ullmann
Biosimilar drug development has brought new challenges to bioanalytical ligand-binding assays used to determine drug concentration, antidrug antibodies and neutralizing antibodies. One particular challenge is how to demonstrate that the antidrug antibody assay can adequately detect antibodies against both biosimilar and originator. In this paper, we review the current guidelines and literature for practical recommendations and present a gap analysis. Case examples of antibody binding comparability testing are presented, and the challenges and implications are discussed...
September 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28912408/-results-of-a-drug-use-survey-of-filgrastim-biosimilar-1-filgrastim-bs-syringe-for-inj-mochida-and-f
#9
Tsukasa Teshima, Nao Takigawa, Yuki Makita, Chinatsu Kushiya
With the aim of evaluating the safety and efficacy of filgrastim biosimilar 1(Filgrastim BS syringe for Inj. "MOCHIDA"and "F"), we conducted a drug use results survey of this product for its indications, including mobilization of hematopoietic stem cells into peripheral blood and chemotherapy-induced neutropenia. Of the 518 cases enrolled between August 2013 and July 2015, 495 were selected to be subjects of our safety and efficacy evaluations. 37 cases (7.47%)experienced side effects, which were mainly lower back pain(19, 3...
September 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28905423/who-standards-for-biotherapeutics-including-biosimilars-an-example-of-the-evaluation-of-complex-biological-products
#10
REVIEW
Ivana Knezevic, Elwyn Griffiths
The most advanced regulatory processes for complex biological products have been put in place in many countries to provide appropriate regulatory oversight of biotherapeutic products in general, and similar biotherapeutics in particular. This process is still ongoing and requires regular updates to national regulatory requirements in line with scientific developments and up-to-date standards. For this purpose, strong knowledge of and expertise in evaluating biotherapeutics in general and similar biotherapeutic products, also called biosimilars, in particular is essential...
September 14, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28903545/the-road-from-development-to-approval-evaluating-the-body-of-evidence-to-confirm-biosimilarity
#11
Paul Declerck, Mourad Farouk Rezk
Biosimilars are products that contain a similar version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). Their development requires special consideration, as similarity to the reference agent needs to be established through a comprehensive comparability exercise. Given the complex nature of these agents, minor structural differences may emerge, but the process of biosimilarity determination is designed to ascertain that the nature and impact of these differences are not clinically significant...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28903544/the-process-defines-the-product-what-really-matters-in-biosimilar-design-and-production
#12
Arnold G Vulto, Orlando A Jaquez
Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during the manufacturing process. The extent of the variation in each of the CQAs must be characterized for the originator molecule and systematically matched as closely as possible by the biosimilar developer to ensure bio-similarity...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28903543/biosimilars-in-rheumatology-a-review-of-the-evidence-and-their-place-in-the-treatment-algorithm
#13
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/28903542/reviewing-the-evidence-for-biosimilars-key-insights-lessons-learned-and-future-horizons
#14
Till Uhlig, Guro L Goll
Biologic therapies have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Over recent years, the development and licensing pathways for biosimilars have become more standardized, and several biosimilars have been made available for patients with inflammatory rheumatic diseases, such as RA. Pre-licensing requirements for biosimilars mandate the demonstration of comparability with reference products in terms of clinical activity, safety and immunogenicity, whereas post-marketing surveillance and risk minimization requirements are set in place to ensure that long-term, real-world safety data are collected to assess biosimilars in clinical practice...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28903541/addressing-unmet-clinical-needs-the-potential-of-biosimilars-in-the-treatment-of-rheumatic-diseases
#15
Hendrik Schulze-Koops
No abstract text is available yet for this article.
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28902041/switching-from-reference-infliximab-to-ct-p13-in-patients-with-inflammatory-bowel-disease-12-months-results
#16
Federico Argüelles-Arias, Maria Fernanda Guerra Veloz, Raul Perea Amarillo, Angel Vilches-Arenas, Luisa Castro Laria, Belen Maldonado Pérez, Dina Chaaro Benallal, Antonio Benítez Roldán, Vicente Merino, Gabriel Ramirez, Miguel Angel Calleja-Hernández, Angel Caunedo Álvarez, Manuel Romero Gómez
BACKGROUND: Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. MATERIALS AND METHODS: This was a prospective single-center observational study in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC)...
September 15, 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28901715/engineering-microbial-metabolite-dynamics-and-heterogeneity
#17
REVIEW
Alexander C Schmitz, Christopher J Hartline, Fuzhong Zhang
Monoclonal antibodies currently dominate the biopharmaceutical market with growing sales having reached 80 billion USD in 2016. As most top-selling mAbs are approaching the end of their patent life, biopharmaceutical companies compete fiercely in the biosimilars market. These two factors present a strong motivation for alternative process strategies and process optimization. In this work a novel purification strategy for monoclonal antibodies comprising phenylboronic acid multimodal chromatography for capture followed by polishing by ion exchange monolithic chromatography and packed bed hydrophobic interaction chromatography is presented and compared to the traditional protein-A-based process...
September 13, 2017: Biotechnology Journal
https://www.readbyqxmd.com/read/28901658/monoclonal-antibodies-production-platforms-an-opportunity-study-of-a-non-protein-a-chromatographic-platform-based-on-process-economics
#18
António Lima Grilo, Marilia Mateus, M Raquel Aires-Barros, Ana M Azevedo
Monoclonal antibodies currently dominate the biopharmaceutical market with growing sales having reached 80 billion USD in 2016. As most top-selling mAbs are approaching the end of their patent life, biopharmaceutical companies compete fiercely in the biosimilars market. These two factors present a strong motivation for alternative process strategies and process optimization. In this work a novel purification strategy for monoclonal antibodies comprising phenylboronic acid multimodal chromatography for capture followed by polishing by ion exchange monolithic chromatography and packed bed hydrophobic interaction chromatography is presented and compared to the traditional protein-A-based process...
September 13, 2017: Biotechnology Journal
https://www.readbyqxmd.com/read/28898594/european-perspective-on-biosimilars
#19
Håkan Mellstedt
No abstract text is available yet for this article.
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28898593/biosimilars-implications-for-clinical-practice
#20
Robert M Rifkin, Susan R Peck
In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The patents of several widely used biologic cancer therapies (including trastuzumab, rituximab, bevacizumab, cetuximab, and pegfilgrastim) are recently expired or due to expire in the near future, so the introduction of biosimilars into the oncology treatment armamentarium is imminent...
September 2017: Journal of Oncology Practice
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