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https://www.readbyqxmd.com/read/28105549/automated-antibody-de-novo-sequencing-and-its-utility-in-biopharmaceutical-discovery
#1
K Ilker Sen, Wilfred H Tang, Shruti Nayak, Yong J Kil, Marshall Bern, Berk Ozoglu, Beatrix Ueberheide, Darryl Davis, Christopher Becker
Applications of antibody de novo sequencing in the biopharmaceutical industry range from the discovery of new antibody drug candidates to identifying reagents for research and determining the primary structure of innovator products for biosimilar development. When murine, phage display, or patient-derived monoclonal antibodies against a target of interest are available, but the cDNA or the original cell line is not, de novo protein sequencing is required to humanize and recombinantly express these antibodies, followed by in vitro and in vivo testing for functional validation...
January 19, 2017: Journal of the American Society for Mass Spectrometry
https://www.readbyqxmd.com/read/28095262/biosimilars-in-inflammatory-bowel-disease-accumulating-clinical-evidence
#2
Sean McConachie, Sheila M Wilhelm, Pramodini B Kale-Pradhan
Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states...
January 17, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28092307/the-prosit-bio-cohort-a-prospective-observational-study-of-patients-with-inflammatory-bowel-disease-treated-with-infliximab-biosimilar
#3
Gionata Fiorino, Natalia Manetti, Alessandro Armuzzi, Ambrogio Orlando, Angela Variola, Stefanos Bonovas, Fabrizio Bossa, Giovanni Maconi, Renata DʼIncà, Paolo Lionetti, Laura Cantoro, Walter Fries, Maria L Annunziata, Francesco Costa, Maria M Terpin, Livia Biancone, Claudio C Cortelezzi, Arnaldo Amato, Sandro Ardizzone, Silvio Danese, Luisa Guidi, Giulia Rizzuto, Arianna Massella, Angelo Andriulli, Alessandro Massari, Greta Lorenzon, Silvia Ghione, Anna Kohn, Agostino Ventra, Vito Annese
BACKGROUND: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. METHODS: A prospective, multicenter, cohort study using a structured database. RESULTS: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28090158/zarxio-filgrastim-sndz-the-first-biosimilar-approved-by-the-fda
#4
Mina Awad, Pavit Singh, Olga Hilas
Zarxio (filgrastim-sndz), a biosimilar for the treatment of severe chronic neutropenia.
January 2017: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/28088282/conjugation-site-analysis-of-antibody-drug-conjugates-adcs-by-signature-ion-fingerprinting-and-normalized-area-quantitation-approach-using-nano-liquid-chromatography-coupled-to-high-resolution-mass-spectrometry
#5
Hua Sang, Gaoyuan Lu, Yazhong Liu, Qiyue Hu, Weifeng Xing, Dongbing Cui, Fang Zhou, Jingwei Zhang, Haiping Hao, Guangji Wang, Hui Ye
Trastuzumab-MCC-DM1 (T-DM1) is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody (mAb) trastuzumab non-cleavably linked to a cytotoxic drug DM1. During production, the DM1 agents were conjugated to the lysine residues of the mAb in a non-specific manner, yielding a heterogeneous mixture of ADC molecules that differ with respect to both the number and the conjugation sites of DM1 per mAb molecule. Since drug conjugation sites of ADC can significantly impact properties such as stability and pharmacokinetic behaviors, a rapid and reliable approach for conjugation site analysis of ADCs is highly demanded...
February 22, 2017: Analytica Chimica Acta
https://www.readbyqxmd.com/read/28087106/charge-variant-analysis-of-proposed-biosimilar-to-trastuzumab
#6
Pravinkumar Dakshinamurthy, Pavithra Mukunda, Bhargav Prasad Kodaganti, Bharath Ravindra Shenoy, Bairavabalakumar Natarajan, Amol Maliwalave, Vivek Halan, Sathyabalan Murugesan, Sunit Maity
Trastuzumab is a humanized monoclonal antibody (mAb) employed for the treatment of HER2 Positive Breast Cancer. A HER2 overexpressing tumor cell binds to Trastuzumab and attracts immune cells which lead to induction of Antibody Dependent Cellular Cytotoxicity (ADCC) by binding to Fc receptors (CD16a or FcγRIIIa) on an effector cell, such as natural killer (NK) cells. The most commonly expressed receptor on NK cell is CD16a which binds to the Fc portion of Trastuzumab. The ligand-independent HER2-HER3 dimerization is the most potent stimulator of downstream pathways for regulation of cell growth and survival...
January 10, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28078656/biosimilars-for-the-treatment-of-cancer-a-systematic-review-of-published-evidence
#7
REVIEW
Ira Jacobs, Reginald Ewesuedo, Sadiq Lula, Charles Zacharchuk
BACKGROUND: Biologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access. OBJECTIVES: The purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer. METHODS: MEDLINE(®), Embase(®), and ISI Web of Science(®) databases were searched to September 2015...
January 11, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28078434/a-retrospective-open-label-uncontrolled-study-of-epoetin-zeta-on-the-treatment-of-chemotherapy-induced-anemia-in-solid-tumors
#8
Constantinos E Alifieris, Kyriakos Orfanakos, Aristina Papanota, George P Stathopoulos, Nikolaos Sitaras, Dimitrios T Trafalis
PURPOSE: This is a single-center uncontrolled retrospective study to evaluate the efficacy and safety of the biosimilar epoetin zeta after approval in chemotherapy-induced anemia (CIA). METHODS: Patients screened were >18 years old suffering from solid malignancies and CIA with Hg ≤10 or <11 g/dl if symptomatic anemia. Patients had measurable disease by TNM and Eastern Cooperative Oncology Group (ECOG). Patients were treated for at least 12 weeks and the primary endpoint was to determine the incidence of blood transfusions, and secondarily, the overall safety and efficacy defined as ≥1 g/dl rise in Hb concentration or ≥40,000 cells/μl rise in reticulocyte count...
January 11, 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28074074/ibd-in-2016-biologicals-and-biosimilars-in-ibd-the-road-to-personalized-treatment
#9
Krisztina B Gecse, Péter L Lakatos
No abstract text is available yet for this article.
January 11, 2017: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28072827/comprehensive-n-glycan-profiling-of-cetuximab-biosimilar-candidate-by-np-hplc-and-maldi-ms
#10
Sheng Liu, Wenjie Gao, Yao Wang, Zhenyu He, Xiaojun Feng, Bi-Feng Liu, Xin Liu
Monitoring glycosylation of the mAbs have been emphasized and routinely characterized in biopharmaceutical industries because the carbohydrate components are closely related to the safety, efficacy, and consistency of the antibodies. In this study, the comprehensive glycan profiling of a biosimilar candidate of cetuximab was successfully characterized using Normal phase high-performance liquid chromatography (NP-HPLC) in combination with Matrix assisted laser desorption/ionization mass spectrometry (MALDI-MS)...
2017: PloS One
https://www.readbyqxmd.com/read/28068848/the-safety-of-emerging-biosimilar-drugs-for-the-treatment-of-rheumatoid-arthritis
#11
J Braun, J Kay
Biological disease-modifying anti-rheumatic drugs (bDMARDs), often administered in combination with methotrexate, target specific inflammatory mediators and have transformed the treatment of rheumatic diseases, especially rheumatoid arthritis (RA) but also the spondyloarthritides. However, the high cost of these drugs in many countries restricts patient access. As many bDMARDs have reached or are near to patent expiration, numerous biosimilar drugs are in development and some have already been approved. Biosimilars are generally priced lower than their reference products (RPs), or bio-originators, and as prices come down it is hoped that patient access to these drugs will increase, making the safety of these drugs an area of major interest...
January 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28066881/short-acting-erythropoiesis-stimulating-agents-for-anaemia-in-predialysis-patients
#12
REVIEW
Deirdre Hahn, Christopher I Esezobor, Noha Elserafy, Angela C Webster, Elisabeth M Hodson
BACKGROUND: The benefits of erythropoiesis-stimulating agents (ESA) for chronic kidney disease (CKD) patients have been previously demonstrated. However, the efficacy and safety of short-acting epoetins administered at larger doses and reduced frequency as well as of new epoetins and biosimilars remains uncertain. OBJECTIVES: This review aimed to evaluate the benefits and harms of different routes, frequencies and doses of epoetins (epoetin alpha, epoetin beta and other short-acting epoetins) for anaemia in adults and children with CKD not receiving dialysis...
January 9, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28063134/how-can-pricing-and-reimbursement-policies-improve-affordable-access-to-medicines-lessons-learned-from-european-countries
#13
REVIEW
Sabine Vogler, Valérie Paris, Alessandra Ferrario, Veronika J Wirtz, Kees de Joncheere, Peter Schneider, Hanne Bak Pedersen, Guillaume Dedet, Zaheer-Ud-Din Babar
This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging...
January 6, 2017: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/28060699/portuguese-position-paper-on-the-use-of-biosimilars-in-psoriasis
#14
Tiago Torres, Ana Ferreira, Paulo Ferreira, Martinha Henriques, Luiz Leite, Sofia Magina, Gabriela Marques Pinto, Hugo Oliveira, Artur Sousa Basto, Rui Tavares Bello, Paulo Varela, António Massa, Manuela Selores, Paulo Filipe
No abstract text is available yet for this article.
September 2016: Acta Médica Portuguesa
https://www.readbyqxmd.com/read/28060570/adjustment-for-unbalanced-sample-size-for-analytical-biosimilar-equivalence-assessment
#15
Xiaoyu Cassie Dong, Yu-Ting Weng, Yi Tsong
Large sample size imbalance is not uncommon in the biosimilar development. At the beginning of a product development, sample sizes of a biosimilar and a reference product may be limited. Thus a sample size calculation may not be feasible. During the development stage, more batches of reference product may be added at a later stage to have a more reliable estimate of the reference variability. On the other hand, we also need a sufficient number of biosimilar batches in order to have a better understanding of the product...
January 6, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28057166/similar-biologics-global-opportunities-and-issues
#16
Prasanta Kumar Ghosh
The invention and use of a large number of biologics during the last three decades for treating various deficiencies and chronic disorders has resulted in great benefit to human health. Abundant use of these biologics has been considerably constrained due to the reasons of their increased prices, charged by the inventors up to the time up to which their use were/are protected by intellectual property rights (IPR).Some of these biologics are presently being manufactured by the existing and newer companies as "similar biologics" after the IPR on these products have expired and as a result the prices of several such medicines are coming down...
October 2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28056484/-biosimilars-in-inflammatory-bowel-disease-ibd-experiences-and-perceptions-of-german-gastroenterologists
#17
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...
January 5, 2017: Zeitschrift Für Gastroenterologie
https://www.readbyqxmd.com/read/28056413/rituximab-13-open-questions-after-20years-of-clinical-use
#18
REVIEW
Francesca Pavanello, Emanuele Zucca, Michele Ghielmini
Rituximab improved the prognosis of all B-cell derived lymphoproliferative diseases, but despite 20years of intensive use, it remains a drug with a number of still obscure characteristics and unanswered questions. These include the mechanism of action and of resistance, the optimal schedule, the interaction with chemotherapy, as well as predictive factors for response rate and duration. Despite being very well tolerated, the question of its long term side effects and the risks of the administration near to a pregnancy have only recently been addressed...
December 22, 2016: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/28055327/exact-test-based-approach-for-equivalence-test-with-parameter-margin
#19
Xiaoyu Cassie Dong, Yuanyuan Bian, Yi Tsong, Tianhua Wang
The equivalence test has a wide range of applications in pharmaceutical statistics which we need to test for the similarity between two groups. In recent years, the equivalence test has been used in assessing the analytical similarity between a proposed biosimilar product and a reference product. More specifically, the mean values of the two products for a given quality attribute are compared against an equivalence margin in the form of ±f × σR, where ± f × σ R is a function of the reference variability...
January 5, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28053335/an-fda-perspective-on-the-assessment-of-proposed-biosimilar-therapeutic-proteins-in-rheumatology
#20
REVIEW
Nikolay P Nikolov, Marjorie A Shapiro
Biologic products have revolutionized the management of many rheumatic diseases, but access to these products might be limited by their relatively high costs. The US Biologics Price Competition and Innovation Act of 2009, which is contained within the Patient Protection and Affordable Care Act, established an abbreviated pathway for licensure by the FDA of biologic products that are demonstrated to be biosimilar to or interchangeable with FDA-licensed biologic products, termed reference products. This law allows for the approval of biosimilar biologic products, which are expected to increase access to treatment for patients, and ensuring the implementation of this Act is a high priority for the FDA...
January 5, 2017: Nature Reviews. Rheumatology
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