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https://www.readbyqxmd.com/read/28637287/pooled-analysis-of-two-randomized-double-blind-trials-comparing-proposed-biosimilar-la-ep2006-with-reference-pegfilgrastim-in-breast-cancer
#1
K Blackwell, P Gascon, C M Jones, A Nixon, A Krendyukov, R Nakov, Y Li, N Harbeck
NCT01735175, NCT01516736.
June 16, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28623625/switching-between-reference-biologics-and-biosimilars-for-the-treatment-of-rheumatology-gastroenterology-and-dermatology-inflammatory-conditions-considerations-for-the-clinician
#2
REVIEW
Robert Moots, Valderilio Azevedo, Javier L Coindreau, Thomas Dörner, Ehab Mahgoub, Eduardo Mysler, Morton Scheinberg, Lisa Marshall
PURPOSE OF REVIEW: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of switching data. RECENT FINDINGS: Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2)...
June 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28622961/zoh%C3%A3-a-prospective-study-of-the-use-of-biosimilar-filgrastim-zarzio-in-clinical-practice-in-patients-treated-with-chemotherapy-for-lymphoid-malignancies
#3
Gandhi Laurent Damaj, Omar Benbrahim, Maya Hacini, Inna Voronina, Khaled Benabed, Ravaka-Fatoma Soumoudronga, Isabelle Gasnereau, Corinne Haioun, Philippe Solal-Céligny
BACKGROUND: The ZOHé study was a prospective, observational, multicenter study in France to assess use of biosimilar filgrastim Zarzio in routine clinical practice in patients undergoing neutropenia-inducing chemotherapy. PATIENTS AND METHODS: Patients ≥ 18 years undergoing chemotherapy for a malignant disease and with a first prescription for Zarzio were enrolled in 2 cohorts: solid tumor (1174 patients) or hematological malignancy (633 patients); the latter is reported here...
June 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28620302/adoption-of-biosimilar-infliximab-for-rheumatoid-arthritis-ankylosing-spondylitis-and-inflammatory-bowel-diseases-in-the-eu5-a-budget-impact-analysis-using-a-delphi-panel
#4
Tim A Kanters, Jelena Stevanovic, Isabelle Huys, Arnold G Vulto, Steven Simoens
Introduction: Introducing biosimilar infliximab for the treatment in rheumatology (rheumatoid arthritis and ankylosing spondylitis) and inflammatory bowel disease (Crohn's disease and ulcerative colitis) may reduce treatment costs associated with biologics. This study aimed to investigate the budget impact of adopting biosimilar infliximab in five European countries, considering that the budget impact includes the adoption of biosimilar infliximab and the availability of biologic alternatives such as vedolizumab, biosimilar etanercept, biosimilar rituximab, and other relevant factors...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28619479/a-demonstration-of-analytical-similarity-comparing-a-proposed-biosimilar-pegfilgrastim-and-reference-pegfilgrastim
#5
Stephen Brokx, Louise Scrocchi, Nirmesh Shah, Jason Dowd
BACKGROUND: Recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) is used primarily to reduce incidence and duration of severe neutropenia and its associated complications in cancer patients that have received a chemotherapy regimen. The pegylated form of filgrastim, "pegfilgrastim", is a long-acting form that requires only a once-per-cycle administration for the management of chemotherapy-induced neutropenia. Apobiologix, a division of ApoPharma USA, Inc., and Intas Pharmaceuticals Limited have co-developed a proposed pegfilgrastim biosimilar to US-licensed pegfilgrastim...
June 12, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28615973/can-biosimilars-help-achieve-the-goals-of-us-health-care-reform
#6
REVIEW
Ralph Boccia, Ira Jacobs, Robert Popovian, Gilberto de Lima Lopes
The US Patient Protection and Affordable Care Act (ACA) aims to expand health care coverage, contain costs, and improve health care quality. Accessibility and affordability of innovative biopharmaceuticals are important to the success of the ACA. As it is substantially more difficult to manufacture them compared with small-molecule drugs, many of which have generic alternatives, biologics may increase drug costs. However, biologics offer demonstrated improvements in patient care that can reduce expensive interventions, thus lowering net health care costs...
2017: Cancer Management and Research
https://www.readbyqxmd.com/read/28612945/comparative-study-of-the-number-of-report-and-time-to-onset-of-the-reported-adverse-event-between-the-biosimilars-and-the-originator-of-filgrastim
#7
Tetsu Kobayashi, Izumi Kamada, Junko Komura, Satoshi Toyoshima, Akiko Ishii-Watabe
PURPOSE: The objective of this study is to specify the most reported adverse events as preferred terms (PTs) and to compare the reported adverse events about some properties including the number of report and time-to-onset (TTO) distribution of the originator of filgrastim Neupogen® and its biosimilars in Europe, using VigiBase®. METHODS: We identified the biosimilar which was reported as the suspected drug in more than 100 individual case safety reports in Europe...
June 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28612180/immunogenicity-of-biologics-in-chronic-inflammatory-diseases-a-systematic-review
#8
REVIEW
Vibeke Strand, Alejandro Balsa, Jamal Al-Saleh, Leonor Barile-Fabris, Takahiko Horiuchi, Tsutomu Takeuchi, Sadiq Lula, Charles Hawes, Blerina Kola, Lisa Marshall
OBJECTIVES: A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety. METHODS: Literature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn's disease, and ulcerative colitis...
June 13, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28612179/efficacy-safety-and-pharmacokinetics-of-up-to-two-courses-of-the-rituximab-biosimilar-ct-p10-versus-innovator-rituximab-in-patients-with-rheumatoid-arthritis-results-up-to-week-72-of-a-phase-i-randomized-controlled-trial
#9
Dae Hyun Yoo, Chang-Hee Suh, Seung Cheol Shim, Slawomir Jeka, Francisco Fidencio Cons Molina, Pawel Hrycaj, Piotr Wiland, Eun Young Lee, Francisco G Medina-Rodriguez, Pavel Shesternya, Sebastiao Radominski, Marina Stanislav, Volodymyr Kovalenko, Dong Hyuk Sheen, Leysan Myasoutova, Mie Jin Lim, Jung-Yoon Choe, Sang Joon Lee, Sung Young Lee, Sung Hwan Kim, Won Park
BACKGROUND: CT-P10 is a biosimilar of innovator rituximab (RTX), a biological therapy used to treat patients with rheumatoid arthritis (RA) who have responded inadequately to anti-tumor necrosis factor agents. OBJECTIVE: Our objective was to compare the clinical profile of CT-P10 versus RTX in patients with RA who received up to two courses of treatment and were followed for up to 72 weeks. METHODS: In this multicenter double-blind phase I study, patients were randomized 2:1 to receive CT-P10 1000 mg or RTX 1000 mg at weeks 0 and 2...
June 13, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28612093/clinical-trial-design-in-juvenile-idiopathic-arthritis
#10
Stephen J Balevic, Mara L Becker, Michael Cohen-Wolkowiez, Laura E Schanberg
Randomized clinical trials provide the gold standard evidence base to guide clinical practice. Despite major advances in trial design, pediatric clinical trials are still difficult to perform and pose unique challenges, including the need to consider the impact of developmental changes in trial design. Advances within pediatric rheumatology combined with the need to comply with legislative requirements have driven new approaches to performing pediatric clinical trials such as utilization of large research networks, incorporation of patient and family stakeholders in the planning and implementation of clinical trials, and the development of novel trial designs...
June 13, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28608570/introduction-of-similar-insulins-in-europe
#11
REVIEW
M Davies, D Dahl, T Heise, J Kiljanski, C Mathieu
Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar(®) ), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered identical to their reference products. Strict regulatory guidelines adopted by authorities in Europe, the USA and some other countries help to ensure that efficacy and safety profiles of biosimilar insulins are not meaningfully different from those of the reference products, preventing entry of biological compounds not meeting quality standards and potentially affecting people's glycaemic outcomes...
June 13, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28607755/access-and-barriers-to-ms-care-in-latin-america
#12
REVIEW
Víctor M Rivera, Miguel Angel Macias
Multiple sclerosis (MS), an epidemiologically emergent disorder in Latin America (LATAM), poses substantial socioeconomic challenges to a region where most countries remain as economies in development. MS is not health priority despite its economic and communitarian impact with a relatively low prevalence. MS treatments in LATAM have evolved from earlier long-term oral steroids and immunosuppression protocols, to platform disease modifying therapies (DMTs), to the current landscape with more advanced therapeutic molecules...
January 2017: Multiple Sclerosis Journal—Experimental, Translational and Clinical
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...
June 9, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28600696/efficacy-and-safety-of-switching-from-innovator-rituximab-to-biosimilar-ct-p10-compared-with-continued-treatment-with-ct-p10-results-of-a-56-week-open-label-study-in-patients-with-rheumatoid-arthritis
#14
Won Park, Chang-Hee Suh, Seung Cheol Shim, Francisco Fidencio Cons Molina, Slawomir Jeka, Francisco G Medina-Rodriguez, Pawel Hrycaj, Piotr Wiland, Eun Young Lee, Pavel Shesternya, Volodymyr Kovalenko, Leysan Myasoutova, Marina Stanislav, Sebastiao Radominski, Mie Jin Lim, Jung-Yoon Choe, Sang Joon Lee, Sung Young Lee, Sung Hwan Kim, Dae Hyun Yoo
BACKGROUND: CT-P10 is a biosimilar candidate of innovator rituximab (RTX) that demonstrated a comparable clinical profile to RTX in a phase I randomized controlled trial (RCT) in rheumatoid arthritis (RA) (ClinicalTrials.gov identifier: NCT01534884). OBJECTIVE: This open-label extension (OLE) study (NCT01873443) compared the efficacy and safety of CT-P10 in patients with RA who received CT-P10 from the outset (i.e., from the start of the RCT and also in the OLE; 'maintenance group') with those who received RTX during the RCT and switched to CT-P10 during the OLE ('switch group')...
June 9, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28596257/developments-in-molecular-testing-and-biosimilars
#15
Katy Winckworth-Prejsnar, Elizabeth A Nardi, Lisa Korin Lentz, Jeffrey A Crawford, C Lyn Fitzgerald, Robert W Carlson
Molecular testing and biosimilars offer the potential for increased access to targeted treatment options and reduction in healthcare costs, but come with significant challenges in ensuring patient access to innovation in cancer care while maintaining safe, effective, ethical, and affordable treatment options. As providers, payers, patients, and the larger healthcare systems become inundated with a wide variety of molecular diagnostics and an increased number of biosimilars coming to market, it will be important to understand regulatory guidance and policy implications relating to the appropriateness of molecular testing and the clinical use of biosimilars in cancer care...
June 2017: Journal of the National Comprehensive Cancer Network: JNCCN
https://www.readbyqxmd.com/read/28594963/biosimilars-curb-your-enthusiasm
#16
Y Tony Yang, Brian Chen, Charles L Bennett
No abstract text is available yet for this article.
June 8, 2017: JAMA Oncology
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
#17
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/28592386/ct-p6-compared-with-reference-trastuzumab-for-her2-positive-breast-cancer-a-randomised-double-blind-active-controlled-phase-3-equivalence-trial
#18
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...
June 2, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28588966/challenges-constraining-access-to-insulin-in-the-private-sector-market-of-delhi-india
#19
Abhishek Sharma, Warren A Kaplan
OBJECTIVE: India's majority of patients-including those living with diabetes-seek healthcare in the private sector through out-of-pocket (OOP) payments. We studied access to insulin in the private-sector market of Delhi state, India. METHODS: A modified World Health Organization/Health Action International (WHO/HAI) standard survey to assess insulin availability and prices, and qualitative interviews with insulin retailers (pharmacists) and wholesalers to understand insulin market dynamics...
November 2016: BMJ Global Health
https://www.readbyqxmd.com/read/28587560/effectiveness-of-originator-neupogen-and-biosimilar-zarzio-filgrastim-in-autologous-peripheral-blood-stem-cell-mobilization-in-adults-with-acute-myeloid-leukemia-a-single-center-retrospective-study
#20
Vincenzo Nasillo, Ambra Paolini, Giovanni Riva, Monica Morselli, Leonardo Potenza, Valeria Coluccio, Monica Maccaferri, Elisabetta Colaci, Valeria Fantuzzi, Andrea Messerotti, Laura Arletti, Valeria Pioli, Elisabetta Lugli, Andrea Gilioli, Chiara Quadrelli, Patrizia Zucchini, Daniela Vallerini, Ivana Lagreca, Patrizia Barozzi, Angela Cuoghi, Paola Bresciani, Roberto Marasca, Maria Teresa Mariano, Giovanni Ceccherelli, Patrizia Comoli, Daniele Campioli, Tommaso Trenti, Franco Narni, Mario Luppi, Fabio Forghieri
No abstract text is available yet for this article.
June 7, 2017: Leukemia & Lymphoma
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