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Rituximab Biosimilar

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https://read.qxmd.com/read/30747341/in-use-stability-of-the-rituximab-biosimilar-ct-p10-truxima-%C3%A2-following-preparation-for-intravenous-infusion-and-storage
#1
Su Jung Kim, Kwang Woo Kim, Yeon Kyeong Shin, Ji Woong Kwon, Hye Young Kang, Yoon A Park, Ji Young Shin, So Young Kim, Won Yong Han
BACKGROUND: CT-P10 is the first biosimilar of the anti-CD20 monoclonal antibody, rituximab. CT-P10 is currently available in over 51 countries worldwide, where it is approved in the same indications as its reference product rituximab. In-use stability studies are conducted for biologics to determine how conditions (e.g., temperature, light, humidity, length of time stored) affect drug quality following dilution and storage in infusion bags. OBJECTIVE: We evaluated the in-use stability of CT-P10 for intravenous infusion stored diluted in infusion bags over longer periods than currently recommended by manufacturer guidelines...
February 11, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30719632/long-term-efficacy-and-safety-of-biosimilar-ct-p10-versus-innovator-rituximab-in-rheumatoid-arthritis-48-week-results-from-a-randomized-phase-iii-trial
#2
Chang-Hee Suh, Dae Hyun Yoo, Alfredo Berrocal Kasay, Elia Chalouhi El-Khouri, Francisco Fidenci Cons Molina, Pavel Shesternya, Pedro Miranda, Francisco G Medina-Rodriguez, Piotr Wiland, Slawomir Jeka, Jose Chavez-Corrales, Thomas Linde, Pawel Hrycaj, Mauricio Abello-Banfi, Ihor Hospodarskyy, Janusz Jaworski, Mariusz Piotrowski, Marek Brzosko, Marek Krogulec, Sergii Shevchuk, Armando Calvo, Daina Andersone, Won Park, Seung Cheol Shim, Sang Joon Lee, Sung Young Lee
OBJECTIVE: The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. METHODS: In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates...
February 5, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30710098/aptamers-as-quality-control-tool-for-production-storage-and-biosimilarity-of-the-anti-cd20-biopharmaceutical-rituximab
#3
Sabrina Wildner, Sara Huber, Christof Regl, Christian G Huber, Urs Lohrig, Gabriele Gadermaier
Detailed analysis of biopharmaceuticals is crucial for safety, efficacy and stability. Aptamers, which are folded, single-stranded oligonucleotides, can be used as surrogate antibodies to detect subtle conformational changes. We aimed to generate and assess DNA aptamers against the therapeutic anti-CD20 antibody rituximab. Six rituximab-specific aptamers with Kd  = 354-887 nM were obtained using the magnetic bead-based systematic evolution of ligands by exponential enrichment (SELEX) technology. Aptamer folds were analysed by online prediction tools and circular dichroism spectroscopy suggesting quadruplex structures for two aptamers while others present B-DNA helices...
February 1, 2019: Scientific Reports
https://read.qxmd.com/read/30613169/review-of-biologics-biosimilars-and-intended-copies-in-rheumatology-and-current-practice-in-iraq
#4
REVIEW
Nizar Abdulateef Al Ani, Faiq I Gorial, Saad Al-Sulaitti, Jasmine Abbas Humadi, Nabaa Ihsan Awadh, Mohamed Mounir, Yasser El Dershaby, Heather Jones, Nancy Sunna
Biologic therapies are an important option in the treatment of patients with rheumatic disease. As the development of potential biosimilars increases, many countries are following the guidelines developed by the WHO, European Medicines Agency, or US Food and Drug Administration to create country-specific regulations for the review and approval of these products. Iraq does not yet have such regulations, and this presents a potential safety concern for patients. The analytical, nonclinical, and clinical data requirements for approval of a potential biosimilar are specific and scientifically rigorous...
2019: Open Access Rheumatology: Research and Reviews
https://read.qxmd.com/read/30600193/biosimilarity-assessment-of-biosimilar-therapeutic-monoclonal-antibodies
#5
REVIEW
Akiko Ishii-Watabe, Takashi Kuwabara
The concept of biosimilar was established in the early 2000s in EU. Currently, the regulatory framework for biosimilar has also been established in the US, Japan, and other countries. As of 2018, biosimilars for infliximab, adalimumab, rituximab, trastuzumab, and bevacizumab have been approved. During the development of a biosimilar, product quality should be evaluated and compared with those of the reference product extensively. Among the quality attributes of therapeutic antibodies, FcRn binding and related structures are well known to affect the pharmacokinetic profile of the product...
December 7, 2018: Drug Metabolism and Pharmacokinetics
https://read.qxmd.com/read/30574867/comparative-efficacy-and-safety-of-biosimilar-rituximab-and-originator-rituximab-in-combination-with-methotrexate-in-patients-with-active-rheumatoid-arthritis-a-bayesian-network-meta-analysis
#6
Sang-Cheol Bae, Young Ho Lee
OBJECTIVE: We aimed to assess the relative efficacy and safety of biosimilar rituximab and originator rituximab plus methotrexate (MTX) compared to those of placebo plus MTX in patients with active rheumatoid arthritis (RA). MATERIALS AND METHODS: We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) that examined the efficacy and safety of biosimilar+MTX and rituximab+MTX versus placebo+MTX (MTX group) in patients with active RA despite treatment with MTX and/or tumor necrosis factor (TNF) blockers...
December 21, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://read.qxmd.com/read/30572130/the-future-landscape-of-biosimilars-in-rheumatology-where-we-are-where-we-are-going
#7
REVIEW
Morton Scheinberg, Valderilio Azevedo
INTRODUCTION: The upcoming of biosimilars in rheumatic diseases have generated considerable interest throughout the past five years among pharmaceutical industries and regulatory agencies, their development is associated with considerable variation and heterogeneity on the variable requirements for license and marketing throughout the various continents. AIM: In this article we reviewed the contents of the conference presented on the last XI International Conference in Autoimmunity in Lisbon...
December 18, 2018: Autoimmunity Reviews
https://read.qxmd.com/read/30552149/truxima-gets-high-marks-from-physicians
#8
(no author information available yet)
Doctors are convinced that Truxima, the first rituximab biosimilar approved by the FDA, is as effective as rituximab; European experience with the biosimilar over the last 2 years has also revealed no problems with unexpected side effects. However, cost will be a factor in determining whether doctors in the United States prescribe Truxima instead of rituximab.
December 14, 2018: Cancer Discovery
https://read.qxmd.com/read/30548485/myelodysplastic-syndrome-and-acute-myeloid-leukemia-after-receipt-of-granulocyte-colony-stimulating-factors-in-older-patients-with-non-hodgkin-lymphoma
#9
Gregory S Calip, Kellyn M Moran, Karen I Sweiss, Pritesh R Patel, Zhaoju Wu, Sruthi Adimadhyam, Todd A Lee, Naomi Y Ko, John G Quigley, Brian C-H Chiu
BACKGROUND: Granulocyte colony-stimulating factors (G-CSFs), which are used for the prevention of complications from chemotherapy-related neutropenia, are linked to the risk of developing second primary myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). The objective of this study was to examine the correlation between using a specific G-CSF agent and the risk of MDS/AML among older patients with non-Hodgkin lymphoma (NHL). METHODS: This was a retrospective cohort study of adults aged >65 years who were diagnosed with first primary NHL between 2001 and 2011...
December 12, 2018: Cancer
https://read.qxmd.com/read/30547368/obinutuzumab-in-combination-with-chemotherapy-for-the-first-line-treatment-of-patients-with-advanced-follicular-lymphoma-an-evidence-review-group-evaluation-of-the-nice-single-technology-appraisal
#10
REVIEW
Frederick W Thielen, Nasuh C Büyükkaramikli, Rob Riemsma, Debra Fayter, Nigel Armstrong, Ching-Yun Wei, Vanesa Huertas Carrera, Kate Misso, Gill Worthy, Jos Kleijnen, Isaac Corro Ramos
The National Institute for Health and Care Excellence (NICE), as part of the institute's single technology appraisal (STA) process, invited the company that makes obinutuzumab (Roche Products Limited) to submit evidence of the clinical and cost effectiveness of the drug in combination with chemotherapy, with or without obinutuzumab as maintenance therapy for adult patients with untreated, advanced follicular lymphoma (FL) in the UK. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Erasmus University Rotterdam, was commissioned to act as the Evidence Review Group (ERG)...
December 13, 2018: PharmacoEconomics
https://read.qxmd.com/read/30538425/structural-and-functional-comparability-study-of-anti-cd20-monoclonal-antibody-with-reference-product
#11
Sanjay Kumar Singh, Santosh Pokalwar, Sandip Bose, Shivika Gupta, Suhani Almal, Ranjit Sudhakar Ranbhor
Background: Cell surface protein, CD20, is extensively expressed on the surface of B cells. Antibodies targeting CD20 protein are being used to treat B-cell malignancies and B-cell mediated autoimmune diseases. Considering the cost of therapy with innovator monoclonal antibodies for these diseases, development of biosimilar products for the treatment of such diseases provides affordable solution to rising healthcare costs. Materials and Methods: Reference products of rituximab (six batches) were procured and stored as per manufacturer's instructions...
2018: Biologics: Targets & Therapy
https://read.qxmd.com/read/30483893/anti-cd20-directed-therapy-of-b-cell-lymphomas-are-new-agents-really-better
#12
REVIEW
Ciara L Freeman, Laurie Sehn
PURPOSE OF REVIEW: Since its initial approval in 1997, rituximab has revolutionized the treatment of CD20-positive lymphoproliferative disorders. Now, over two decades later, second-generation molecules are emerging that may have key biological advantages compared to rituximab, as well as biosimilars that may be more cost-effective. Clinicians, health policy makers, and payers will now need to critically appraise the available evidence for these competitors and decide which anti-CD20 to use...
November 27, 2018: Current Oncology Reports
https://read.qxmd.com/read/30389036/efficacy-pharmacokinetics-and-safety-of-the-biosimilar-ct-p10-in-comparison-with-rituximab-in-patients-with-previously-untreated-low-tumour-burden-follicular-lymphoma-a-randomised-double-blind-parallel-group-phase-3-trial
#13
RANDOMIZED CONTROLLED TRIAL
Michinori Ogura, Juan Manuel Sancho, Seok-Goo Cho, Hideyuki Nakazawa, Junji Suzumiya, Gayane Tumyan, Jin Seok Kim, Anne Lennard, José Mariz, Nikolai Ilyin, Wojciech Jurczak, Aurelio Lopez Martinez, Olga Samoilova, Edvard Zhavrid, Eduardo Yañez Ruiz, Marek Trneny, Leslie Popplewell, Bertrand Coiffier, Christian Buske, Won-Seog Kim, Sang Joon Lee, Sung Young Lee, Yun Ju Bae, Larry W Kwak
BACKGROUND: Studies in patients with rheumatoid arthritis and advanced follicular lymphoma have shown that CT-P10, a rituximab biosimilar, has equivalent or non-inferior efficacy and pharmacokinetics to rituximab. We aimed to assess the therapeutic equivalence of single-agent CT-P10 and rituximab in patients with newly diagnosed low-tumour burden follicular lymphoma. METHODS: In this ongoing, randomised, double-blind, parallel-group, active-controlled, phase 3 trial, adult patients (≥18 years) with stage II-IV low-tumour-burden follicular lymphoma were randomly assigned (1:1) using an interactive web or voice response system stratified by region, stage, and age to CT-P10 or US-sourced rituximab...
November 2018: Lancet Haematology
https://read.qxmd.com/read/30296716/assessment-of-the-higher-order-structure-of-humira%C3%A2-remicade%C3%A2-avastin%C3%A2-rituxan%C3%A2-herceptin%C3%A2-and-enbrel%C3%A2-by-2d-nmr-fingerprinting
#14
Derek J Hodgson, Houman Ghasriani, Yves Aubin
The advent of monoclonal antibody biosimilar products has stimulated the development of analytical methods that can better characterize an important quality attribute, namely the higher order structure (HOS). Here, we propose a simple approach based on heteronuclear 2D NMR techniques at natural abundance for generating spectral fingerprints of the HOS at high resolution. We show that the proposed method can assess the HOS of six therapeutic products, adalimumab (Humira®), bevacizumab (Avastin®), infliximab (Remicade®), rituximab (Rituxan®), trastuzumab (Herceptin®), and Etanercept (Enbrel®)...
January 30, 2019: Journal of Pharmaceutical and Biomedical Analysis
https://read.qxmd.com/read/30295429/safety-and-immunogenicity-of-rituximab-biosimilar-gp2013-after-switch-from-reference-rituximab-in-patients-with-active-rheumatoid-arthritis
#15
Hans-Peter Tony, Klaus Krüger, Stanley Cohen, Hendrik Schulze-Koops, Alan Kivitz, Slawomir Jeka, Edit Vereckei, Liyi Cen, Laura Kring, Dmitrij Kollins
OBJECTIVES: Comparable clinical efficacy of the rituximab biosimilar GP2013 and reference rituximab (RTX) has been established in blinded randomized trials. However, when switching from a reference biologic to a biosimilar, potential safety implications are often an important consideration. Therefore, this study evaluated the safety of switching from reference RTX to rituximab biosimilar GP2013, compared with treatment continuation with reference RTX, in patients with rheumatoid arthritis (RA)...
October 8, 2018: Arthritis Care & Research
https://read.qxmd.com/read/30294275/comparative-price-analysis-of-biological-products-for-treatment-of-rheumatoid-arthritis
#16
Manoela Manova, Alexandra Savova, Maria Vasileva, Silvia Terezova, Maria Kamusheva, Daniela Grekova, Valentina Petkova, Guenka Petrova
Biological products for treatment of rheumatoid arthritis usually are cost effective for healthcare systems in Europe, but they are huge financial burden due to the high number of patients and the significant budget impact. The expected saving from introduction on the market of biosimilars are significant and are linked to better access and affordability. The aim of this study was to conduct comparative price analysis of biological products for rheumatoid arthritis therapy among seventeen EU countries. The point of view is that of the Bulgarian pricing and reimbursement system and the chosen countries are those from external reference basket for prices comparison at manufacturing level...
2018: Frontiers in Pharmacology
https://read.qxmd.com/read/30244082/biosimilar-medicines-used-for-cancer-therapy-in-europe-a-review
#17
REVIEW
Sofia B Santos, José M Sousa Lobo, Ana C Silva
This article provides an updated review of the biosimilar medicines approved for cancer therapy in the European Union (EU). First we discuss the most relevant aspects for the development and approval of biosimilar medicines. We then present the oncological biosimilar drugs currently used, which include epoetins (alpha and zeta), filgrastim, and monoclonal antibodies (rituximab, trastuzumab and bevacizumab). Among the clinical applications of biosimilar medicines, cancer therapy remains the main target area and more approved biosimilars are expected over the next few years, providing cost-effective drugs to more patients...
September 19, 2018: Drug Discovery Today
https://read.qxmd.com/read/30233768/a-double-blind-randomized-comparison-study-between-zytux%C3%A2-vs-mabthera%C3%A2-in-treatment-of-cll-with-fcr-regimen-non-inferiority-clinical-trial
#18
Gholamreza Toogeh, Mohammad Faranoush, Seyed Mohsen Razavi, Hassan Jalaeikhoo, Abolghasem Allahyari, Mohammad Reza Ravanbod, Fariba Zarrabi, Vahid Fallahazad, Ehsan Rezaei Darzi, Shadi Sadat Alizadeh Fard
BACKGROUND: Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux™ in comparison to MabThera® in treatment of CLL. MATERIALS AND METHODS: Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group)...
April 1, 2018: International Journal of Hematology-oncology and Stem Cell Research
https://read.qxmd.com/read/30010481/comparison-of-biosimilar-ct-p10-and-innovator-rituximab-in-patients-with-rheumatoid-arthritis-a-randomized-controlled-phase-3-trial
#19
Won Park, Ljubinka Božić-Majstorović, Dragana Milakovic, Alfredo Berrocal Kasay, Elias Chalouhi El-Khouri, Fedra Irazoque-Palazuelos, Francisco Fidencio Cons Molina, Pavel Shesternya, Pedro Miranda, Francisco G Medina-Rodriguez, Piotr Wiland, Slawomir Jeka, Jose Chavez-Corrales, Olena Garmish, Thomas Linde, Dmytro Rekalov, Pawel Hrycaj, Andreas Krause, Natalia Fomina, Olena Piura, Mauricio Abello-Banfi, Chang-Hee Suh, Seung Cheol Shim, Sang Joon Lee, Sung Young Lee, Sung Hwan Kim, Dae Hyun Yoo
This multinational, randomized, double-blind trial, (ClinicalTrials.gov identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA). Adults with active RA were treated with CT-P10, United States-sourced RTX (US-RTX; Rituxan®), or European Union-sourced RTX (EU-RTX; MabThera®) at weeks 0 and 2. The co-primary pharmacokinetic endpoints were area under the serum concentration-time curve (AUC) from time zero to last measurable concentration (AUC0-last ), AUC from time zero to infinity (AUC0-∞ ), and maximum concentration (Cmax ) after two infusions...
August 2018: MAbs
https://read.qxmd.com/read/29915719/past-present-and-future-of-rituximab-the-world-s-first-oncology-monoclonal-antibody-therapy
#20
REVIEW
Timothy M Pierpont, Candice B Limper, Kristy L Richards
Rituximab is a chimeric mouse/human monoclonal antibody (mAb) therapy with binding specificity to CD20. It was the first therapeutic antibody approved for oncology patients and was the top-selling oncology drug for nearly a decade with sales reaching $8.58 billion in 2016. Since its initial approval in 1997, it has improved outcomes in all B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. Despite widespread use, most mechanistic data have been gathered from in vitro studies while the roles of the various response mechanisms in humans are still largely undetermined...
2018: Frontiers in Oncology
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