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https://www.readbyqxmd.com/read/28807650/current-state-of-biosimilars-in-mexico-the-position-of-the-mexican-college-of-rheumatology-2016
#1
Daniel Xibille, Sandra Carrillo, Gabriela Huerta-Sil, Ramiro Hernández, Leonardo Limón, Guadalupe Olvera-Soto, Luis Javier Jara-Quezada, Abdieel Esquivel, Marcela Pérez-Rodríguez
The present document is a position statement of the Mexican College of Rheumatology on the use of biosimilars in rheumatic diseases. This position considers that biosimilars should be considered as interchangeable, that automatic substitution without previous notice in stable patients during follow-up is not ethical, that the approval of a biosimilar should only be given after exhaustive review of preclinical and clinical data marked by Mexican regulations, that it should be clearly stated in the nomenclature of biologic drugs which is the innovator and which is the biosimilar, that it is not correct to choose a biosimilar as treatment based only on economic reasons or extrapolate indications based only on the approval of the innovator and in the absence of safety and efficacy data for the biosimilar...
August 11, 2017: Reumatología Clinica
https://www.readbyqxmd.com/read/28807110/how-similar-are-the-treatment-responses-to-biosimilars-in-patients-with-psoriasis-a-systematic-review-of-statistical-margins-in-comparative-clinical-trials
#2
Marilyn T Wan, Bruce E Strober, Jashin J Wu, Daniel B Shin, Joel M Gelfand
No abstract text is available yet for this article.
September 2017: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/28804626/efficacy-and-safety-of-biosimilar-filgrastim-in-primary-and-secondary-prevention-of-febrile-neutropenia
#3
Leszek Kraj, Joanna Krawczyk-Lipiec, Joanna Górniewska, Grzegorz Orlik
Neutropenia and febrile neutropenia (FN) are among the most common side effects/complications of chemotherapy. The aim of the present study was to evaluate the practice of the use of biosimilar filgrastim in the primary and secondary prevention of FN, and assess its efficacy and safety. A multi-center, non-interventional epidemiological study of 170 cancer patients aged 23-82 years was conducted. Data were collected via a questionnaire completed based on medical documentation and patient examination over five chemotherapy visits...
August 2017: Biomedical Reports
https://www.readbyqxmd.com/read/28803431/sb2-an-infliximab-biosimilar
#4
Yvette N Lamb, Lesley J Scott, Emma D Deeks
SB2 is a biosimilar of the reference anti-TNF-α antibody infliximab. In May 2015, it was approved in the EU for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. It is also approved in these indications in several other countries, including Korea, the USA and Australia. Characterization of SB2 in preclinical studies showed that it is similar to reference infliximab...
August 12, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28801849/bevacizumab-in-colorectal-cancer-current-role-in-treatment-and-the-potential-of-biosimilars
#5
REVIEW
Lee S Rosen, Ira A Jacobs, Ronald L Burkes
Colorectal cancer (CRC) is a leading cause of tumor-related morbidity and mortality worldwide, with mortality most often attributable to metastatic disease. Bevacizumab, a humanized monoclonal antibody targeting vascular endothelial growth factor, has a significant role in the treatment of metastatic CRC (mCRC). However, patient access to bevacizumab may be limited in some regions or circumstances, owing to factors related to insurance coverage, reimbursement, patient out-of-pocket costs, or availability. As a result, outcomes for patients with mCRC may be worsened...
August 11, 2017: Targeted Oncology
https://www.readbyqxmd.com/read/28801752/biosimilar-g-csf-versus-filgrastim-and-lenograstim-in-healthy-unrelated-volunteer-hematopoietic-stem-cell-donors
#6
Roiya Farhan, Elżbieta Urbanowska, Hanna Zborowska, Małgorzata Król, Maria Król, Tigran Torosian, Iwona Piotrowska, Krzysztof Bogusz, Kamila Skwierawska, Wiesław Wiktor-Jędrzejczak, Emilian Snarski
The World Marrow Donor Organization recommends original granulocyte-colony stimulating factor (G-CSF) for the mobilization of stem cells in healthy unrelated hematopoietic stem cell donors. We report the comparison of a biosimilar G-CSF (Zarzio) with two original G-CSFs (filgrastim and lenograstim) in mobilization in unrelated donors. We included data of 313 consecutive donors who were mobilized during the period from October 2014 to March 2016 at the Medical University of Warsaw. The primary endpoints of this study were the efficiency of CD34+ cell mobilization to the circulation and results of the first apheresis...
August 11, 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28797783/results-of-prospective-randomized-open-label-non-inferiority-study-of-tbo-filgrastim-granix-%C3%A2-versus-filgrastim-neupogen-%C3%A2-in-combination-with-plerixafor-for-autologous-stem-cell-mobilization-in-patients-with-multiple-myeloma-or-non-hodgkin-lymphoma
#7
Pavan Kumar Bhamidipati, Mark A Fiala, Brenda J Grossman, John F DiPersio, Keith Stokerl-Goldstein, Feng Gao, Geoffrey L Uy, Peter Westervelt, Mark A Schroeder, Amanda F Cashen, Camille N Abboud, Ravi Vij
Autologous hematopoietic stem cell transplantation (Auto- HSCT) improves survival in multiple myeloma (MM) and Non-Hodgkin lymphoma (NHL). Traditionally, filgrastim (Neupogen® - recombinant G-CSF) has been used in as a single agent or in combination with plerixafor for stem cell mobilization for auto-HSCT. In Europe, recombinant G-CSF biosimilar (Tevagrastim®) is approved for various indications similar to reference filgrastim, including stem cell mobilization for auto-HSCT; However, tbo- Filgrastim (Granix®) is registered under original biologic application and is not approved for stem cell mobilization in the USA...
August 7, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28796564/factors-influencing-the-economics-of-biosimilars-in-the-us
#8
Stanton R Mehr, Richard A Brook
No abstract text is available yet for this article.
August 10, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28794078/long-term-efficacy-and-safety-in-patients-with-rheumatoid-arthritis-continuing-on-sb4-or-switching-from-reference-etanercept-to-sb4
#9
Paul Emery, Jiří Vencovský, Anna Sylwestrzak, Piotr Leszczyński, Wieslawa Porawska, Barbara Stasiuk, Joanna Hilt, Zdenka Mosterova, Soo Yeon Cheong, Jeehoon Ghil
OBJECTIVES: SB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In a randomised, double-blind, 52-week study, SB4 demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA). The open-label extension period evaluated long-term efficacy, safety and immunogenicity when continuing SB4 versus switching from ETN to SB4. METHODS: In the randomised, double-blind phase, patients received weekly subcutaneous administration of 50 mg SB4 or ETN with background methotrexate for up to 52 weeks...
August 9, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28776140/biosimilar-drugs-for-inflammatory-bowel-disease-is-similar-good-enough
#10
EDITORIAL
Mariangela Allocca, Gionata Fiorino, Silvio Danese
No abstract text is available yet for this article.
August 3, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28770499/erratum-to-a-global-reference-comparator-for-biosimilar-development
#11
Christopher J Webster, Gillian R Woollett
No abstract text is available yet for this article.
August 2, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28766389/pharmacokinetics-efficacy-and-safety-of-the-rituximab-biosimilar-ct-p10
#12
Bertrand Coiffier
Rituximab, an anti-CD20 monoclonal antibody, is a key therapeutic in the treatment of B cell lymphomas and rheumatoid arthritis (RA). Global rates of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and RA are increasing, with a concomitant rise in individual and overall treatment costs. As such, biosimilar development may help facilitate greater access to treatment. The rituximab biosimilar CT-P10 (Truxima®) has recently received approval in Europe and South Korea for all indications held by reference rituximab (RTX)...
August 2, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28762192/a-comprehensive-review-on-copemyl-%C3%A2
#13
REVIEW
Pietro Annovazzi, Antonio Bertolotto, Vincenzo Brescia Morra, Claudio Gasperini, Enrico Montanari, Pierluigi Navarra, Francesco Patti, Maria Pia Sormani, Angelo Ghezzi
Economic sustainability is of paramount importance in the rapidly evolving therapeutic scenario of multiple sclerosis (MS). Glatiramoids are a class of drugs whose forefather, glatiramer acetate, has been used as a disease modifying drug (DMD) in patients with MS for over 20 years. Its patent expired in 2015; new versions of such drug are nowadays available on the market, potentially contributing to lowering prices and enhancing a better allocation of economic resources. In this review, we analyze the recommendations underlying the approval of both generic drugs and biosimilars by regulatory authorities, and we provide methodological tools to contextualize the design of studies on these new classes of drugs...
July 31, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28760370/what-nmr-can-do-in-the-biopharmaceutical-industry
#14
REVIEW
Róbert Kiss, Ádám Fizil, Csaba Szántay
Nuclear magnetic resonance (NMR) spectroscopy has a unique capability to probe the primary and higher order molecular structure and the structural dynamics of biomolecules at an atomic resolution, and this capability has been greatly fortified over the last five decades by an astonishing NMR instrumental and methodological development. Because of these factors, NMR has become a primary tool for the structure investigation of biomolecules, spawning a whole scientific subfield dedicated to the subject. This role of NMR is by now well established and broadly appreciated, especially in the context of academic research dealing with proteins that are purified and isotope-labeled in order to facilitate the necessary sophisticated multidimensional NMR measurements...
July 8, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28757626/patent-watch-supreme-court-decision-favours-biosimilars
#15
Courtenay C Brinckerhoff
No abstract text is available yet for this article.
July 31, 2017: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/28755394/clinical-similarity-of-the-biosimilar-abp%C3%A2-501-compared-with-adalimumab-after-single-transition-long-term-results-from-a-randomised-double-blind-52-week-phase-3-study-in-moderate-to-severe-plaque-psoriasis-patients
#16
K Papp, H Bachelez, A Costanzo, P Foley, M Gooderham, P Kaur, S Philipp, L Spelman, N Zhang, B Strober
BACKGROUND: ABP 501, an FDA- and EMA-approved biosimilar, is highly similar to adalimumab in structure, function, and pharmacokinetics. OBJECTIVE: Demonstrate similarity in efficacy, safety, and immunogenicity of ABP 501 versus adalimumab for moderate-to-severe plaque psoriasis. METHODS: Patients were randomised (1:1) to receive ABP 501 or adalimumab 40 mg every 2 weeks for 16 weeks. At Week 16, patients with ≥50% improvement from baseline in psoriasis area-and-severity index score (PASI) were eligible to continue to Week 52...
July 28, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28754191/biosimilars-an-optimistic-outlook-but-vigilance-is-needed
#17
EDITORIAL
The Lancet Haematology
No abstract text is available yet for this article.
August 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28752242/patients-understanding-and-attitudes-towards-infliximab-and-etanercept-biosimilars-result-of-a-uk-web-based-survey
#18
Mohammed I Aladul, Raymond W Fitzpatrick, Stephen R Chapman
BACKGROUND: Infliximab and etanercept biosimilars present significant potential cost savings to the NHS. Patients need to be involved in the decision to use these medicines but there is limited published literature on their knowledge and attitudes about these biosimilars. OBJECTIVES: The aim of this study was to investigate ankylosing spondylitis and rheumatoid arthritis patients' knowledge and attitudes towards infliximab and etanercept biosimilars in the UK. METHODS: A self-administered web survey was conducted among the members of the National Rheumatoid Arthritis Society and the National Ankylosing Spondylitis Society in the UK between 2 March 2017 and 2 June 2017...
July 27, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28740623/patient-access-to-reimbursed-biological-disease-modifying-antirheumatic-drugs-in-the-european-region
#19
Zoltán Kaló, Zoltán Vokó, Andrew Östör, Emma Clifton-Brown, Radu Vasilescu, Alysia Battersby, Edward Gibson
Background & Objectives: Biological disease-modifying antirheumatic drugs (bDMARDs) for the treatment of rheumatoid arthritis (RA) are not always accessible to all patients in accordance with international guidelines, partly owing to their high direct costs against a background of restricted healthcare budgets. This study compares the size of RA patient populations with access to reimbursed bDMARDs across 37 European countries, Russia, and Turkey, according to their treatment eligibility defined by European League Against Rheumatism (EULAR) recommendations and national reimbursement criteria...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28740617/supply-side-and-demand-side-policies-for-biosimilars-an-overview-in-10-european-member-states
#20
Cécile Rémuzat, Anna Kapuśniak, Aleksandra Caban, Dan Ionescu, Guerric Radière, Cyril Mendoza, Mondher Toumi
This study aimed to provide an overview of biosimilar policies in 10 EU MSs. Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries. Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries...
2017: Journal of Market Access & Health Policy
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