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trastuzumab biosimilar

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https://www.readbyqxmd.com/read/29350568/abp-980-promising-trastuzumab-biosimilar-for-her2-positive-breast-cancer
#1
Elisavet Paplomata, Rita Nahta
Approval of the HER2-targeted antibody trastuzumab dramatically improved outcomes for patients with HER2-positive breast cancer. Multiple trastuzumab biosimilars, including ABP 980, are in clinical development. Biosimilars are not identical to the reference biologic, but exhibit equivalence and safety in analytical and clinical studies. Areas covered: A brief introduction to trastuzumab, overview of trastuzumab biosimilars, and detailed review of ABP 980 preclinical and clinical studies are included. We searched PubMed and 2016-2017 ASCO and ESMO conference proceedings for "ABP 980" or "trastuzumab biosimilar"...
January 19, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29330636/a-randomised-trial-comparing-the-pharmacokinetics-and-safety-of-the-biosimilar-ct-p6-with-reference-trastuzumab
#2
Francisco J Esteva, Justin Stebbing, Rebecca N Wood-Horrall, Peter J Winkle, Sung Young Lee, Sang Joon Lee
PURPOSE: Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin®) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. METHODS: We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males...
January 12, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29273617/fda-approves-trastuzumab-biosimilar
#3
(no author information available yet)
On December 1, the FDA approved a second cancer biosimilar, trastuzumab-dkst. The drug was approved to treat patients with HER2-positive breast and metastatic stomach cancers.
December 22, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/29173192/the-ecstacy-of-gold-patent-expirations-for-trastuzumab-bevacizumab-rituximab-and-cetuximab
#4
Tasha R Serna-Gallegos, Krishnansu S Tewari, Christopher J LaFargue
BACKGROUND: Fully humanized monoclonal antibodies have revolutionized the treatment of many solid tumors, including breast, lung, colorectal, and ovarian cancer. Among the most widely used monoclonal antibodies in clinical oncology are cetuximab, trastuzumab, rituximab, and bevacizumab. OBJECTIVE: This article will review these four notable monoclonal antibodies, their role in clinical oncology, and the drug patents that are nearing expiration. RESULTS: They are used in both first and second line treatment regimens for multiple common malignancies...
November 22, 2017: Recent Patents on Biotechnology
https://www.readbyqxmd.com/read/29129095/trastuzumab-biosimilar-in-early-breast-cancer-setting-will-there-be-direct-patient-benefits
#5
Arlene Chan
No abstract text is available yet for this article.
October 2017: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/29094099/improving-access-to-cancer-treatments-the-role-of-biosimilars
#6
Rakesh Chopra, Gilberto Lopes
Biologics play a key role in cancer treatment and are principal components of many therapeutic regimens. However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply. The cost of biologics limits accessibility of cancer treatment for many patients. Effective and affordable cancer therapies are needed globally, more so in developing countries, where health care resources can be limited. Biosimilars, which have biologic activity comparable to their corresponding reference drugs and are often more cost effective, have the potential to enhance treatment accessibility for patients and provide alternatives for decision makers (ie, prescribers, regulators, payers, policymakers, and drug developers)...
October 2017: Journal of Global Oncology
https://www.readbyqxmd.com/read/29076054/prevalence-of-use-and-cost-of-biological-drugs-for-cancer-treatment-a-5-year-picture-from-southern-italy
#7
Simona Lucchesi, Ilaria Marcianò, Paolo Panagia, Rosanna Intelisano, Maria Pia Randazzo, Carmela Sgroi, Giuseppe Altavilla, Mariacarmela Santarpia, Vincenzo Adamo, Tindara Franchina, Francesco Ferraù, Paolina Reitano, Gianluca Trifirò
BACKGROUND AND OBJECTIVES: Considering the clinical and economic burden of biological drugs in cancer treatment, it is necessary to explore how these drugs are used in routine care in Italy and how they affect the sustainability of the National Health Services. This study aimed to investigate the prevalence of use and costs of biological drugs for cancer treatment in a general population of Southern Italy in the years 2010-2014. METHODS: This was a retrospective, observational study using data from the healthcare administrative databases of Messina Province for the years 2010-2014...
October 26, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29061013/-the-development-of-biosimilars-in-oncology
#8
S Y Jiang, Y K Shi
With the extensive application in clinical practice, biological medicine plays a significant role in both treatment and supportive care in oncology. With the expiration of original drug patents, biosimilars emerge. The biosimilars are defined as biological drugs that are be highly similar but not identical to the biological reference. Their development and evaluation procedure are different from those of small molecular chemical generics. Biosimilars are expected to reduce the health care costs worldwide. The booming developments of biosimilars, such as rituximab, trastuzumab and bevacizumab in medical oncology can optimize the clinical strategies, offer patients more treatment options and reduce the medical expenditure...
October 23, 2017: Zhonghua Zhong Liu za Zhi [Chinese Journal of Oncology]
https://www.readbyqxmd.com/read/28898593/biosimilars-implications-for-clinical-practice
#9
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
https://www.readbyqxmd.com/read/28898589/science-of-biosimilars
#10
R Donald Harvey
Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28814565/trastuzumab-biosimilar-on-track-for-approval
#11
(no author information available yet)
An FDA expert panel recommended approval of Mylan's MYL-14010, a biosimilar candidate for Genentech's trastuzumab, putting it on track to become the first approved biosimilar for cancer. Experts predict that biosimilars will lead to lower drug prices, but caution that the savings won't be as dramatic as that seen with generics.
August 16, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28664508/correlation-between-expression-of-recombinant-proteins-and-abundance-of-h3k4me3-on-the-enhancer-of-human-cytomegalovirus-major-immediate-early-promoter
#12
Benjamin P C Soo, Julian Tay, Shirelle Ng, Steven C L Ho, Yuansheng Yang, Sheng-Hao Chao
Role of epigenetic regulation in the control of gene expression is well established. The impact of several epigenetic mechanisms, such as DNA methylation and histone acetylation, on recombinant protein production in mammalian cells has been investigated recently. Here we investigate the correlation between the selected epigenetic markers and five trastuzumab biosimilar-producing Chinese hamster ovary (CHO) cell lines in which the expression of trastuzumab is driven by human cytomegalovirus (HCMV) major immediate-early (MIE) promoter...
August 2017: Molecular Biotechnology
https://www.readbyqxmd.com/read/28605680/surrogate-cd16-expressing-effector-cell-lines-for-determining-the-bioactivity-of-therapeutic-monoclonal-antibodies
#13
Shalom A Gurjar, Jeremy P Derrick, Rebecca J Dearman, Robin Thorpe, Simon Hufton, Ian Kimber, Meenu Wadhwa
Traditional antibody dependent cellular cytotoxicity (ADCC) assays use donor derived natural killer (NK) or peripheral blood mononuclear cells, but donor genetic variability and the technically challenging nature of the assay means that alternative in vitro assay formats are required. We explored the utility of two reporter gene cell lines, the J2 and J9, as surrogate effector cells for ADCC assays. Both express the ADCC relevant Fcγ receptor CD16, crosslinking of which leads to firefly luciferase expression...
September 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28592386/ct-p6-compared-with-reference-trastuzumab-for-her2-positive-breast-cancer-a-randomised-double-blind-active-controlled-phase-3-equivalence-trial
#14
RANDOMIZED CONTROLLED TRIAL
Justin Stebbing, Yauheni Baranau, Valeriy Baryash, Alexey Manikhas, Vladimir Moiseyenko, Giorgi Dzagnidze, Edvard Zhavrid, Dmytro Boliukh, Daniil Stroyakovskii, Joanna Pikiel, Alexandru Eniu, Dmitry Komov, Gabriela Morar-Bolba, Rubi K Li, Andriy Rusyn, Sang Joon Lee, Sung Young Lee, Francisco J Esteva
BACKGROUND: CT-P6 is a proposed biosimilar to reference trastuzumab. In this study, we aimed to establish equivalence of CT-P6 to reference trastuzumab in neoadjuvant treatment of HER2-positive early-stage breast cancer. METHODS: In this randomised, double-blind, active-controlled, phase 3 equivalence trial, we recruited women aged 18 years or older with stage I-IIIa operable HER2-positive breast cancer from 112 centres in 23 countries. Inclusion criteria were an Eastern Cooperative Oncology Group performance status score of 0 or 1; a normal left ventricular ejection fraction of at least 55%; adequate bone marrow, hepatic, and renal function; at least one measureable lesion; and known oestrogen and progesterone receptor status...
July 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28371609/trastuzumab-and-pertuzumab-plant-biosimilars-modification-of-asn297-linked-glycan-of-the-mabs-produced-in-a-plant-with-fucosyltransferase-and-xylosyltransferase-gene-knockouts
#15
T V Komarova, E V Sheshukova, E N Kosobokova, M V Serebryakova, V S Kosorukov, V N Tashlitsky, Y L Dorokhov
Plant biosimilars of anticancer therapeutic antibodies are of interest not only because of the prospects of their practical use, but also as an instrument and object for study of plant protein glycosylation. In this work, we first designed a pertuzumab plant biosimilar (PPB) and investigated the composition of its Asn297-linked glycan in comparison with trastuzumab plant biosimilar (TPB). Both biosimilars were produced in wild-type (WT) Nicotiana benthamiana plant (PPB-WT and TPB-WT) and transgenic ΔXTFT N...
April 2017: Biochemistry. Biokhimii︠a︡
https://www.readbyqxmd.com/read/28341959/a-randomized-single-blind-single-dose-study-evaluating-the-pharmacokinetic-equivalence-of-proposed-biosimilar-abp-980-and-trastuzumab-in-healthy-male-subjects
#16
RANDOMIZED CONTROLLED TRIAL
Vladimir Hanes, Vincent Chow, Nan Zhang, Richard Markus
PURPOSE: This study compared the pharmacokinetic (PK) profiles of the proposed biosimilar ABP 980 and trastuzumab in healthy males. METHODS: In this single-blind study, 157 healthy males were randomized 1:1:1 to a single 6 mg/kg intravenous infusion of ABP 980, FDA-licensed trastuzumab [trastuzumab (US)], or EU-authorized trastuzumab [trastuzumab (EU)]. Primary endpoints were area under the serum concentration-time curve from time 0 to infinity (AUCinf) and maximum observed serum concentration (C max)...
May 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28296619/drifts-in-adcc-related-quality-attributes-of-herceptin%C3%A2-impact-on-development-of-a-trastuzumab-biosimilar
#17
Seokkyun Kim, Jinsu Song, Seungkyu Park, Sunyoung Ham, Kyungyeol Paek, Minjung Kang, Yunjung Chae, Heewon Seo, Hyung-Chan Kim, Michael Flores
A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biologic properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019...
May 2017: MAbs
https://www.readbyqxmd.com/read/28236776/evolving-landscape-of-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-treatment-and-the-future-of-biosimilars
#18
REVIEW
Christian Jackisch, Philip Lammers, Ira Jacobs
Human epidermal growth factor receptor 2-positive (HER2+) breast cancer comprises approximately 15%-20% of all breast cancers and is associated with a poor prognosis. The introduction of anti-HER2 therapy has significantly improved clinical outcomes for patients with HER2+ breast cancer, and multiple HER2-directed agents (ie, trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine [T-DM1]) are approved for clinical use in various settings. The treatment landscape for patients with HER2+ breast cancer is continuing to evolve...
April 2017: Breast: Official Journal of the European Society of Mastology
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
#19
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/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
#20
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
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