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https://www.readbyqxmd.com/read/27911675/on-safety-margin-for-drug-interchangeability
#1
Jiayin Zheng, Shein-Chung Chow, Fuyu Song
As more and more generic (or biosimilar) drug products become available in the market place, it is a concern whether the approved generic (or biosimilar) drug products are safe and efficacious and hence can be used interchangeably. According to current regulation, most regulatory agencies such as the United States Food and Drug Administration (FDA) indicate an approved generic (or biosimilar) drug product can serve as a substitute for the innovative drug product. Bioequivalence (biosimilarity) assessment for regulatory approval among generic copies (or biosimilars) of the innovative drug product are not required...
December 2, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27906604/statistical-considerations-regarding-to-correlated-lots-in-analytical-biosimilar-equivalence-test
#2
Meiyu Shen, Tianhua Wang, Yi Tsong
In the evaluation of the analytical similarity data, an equivalence testing approach for most critical and quantitative quality attributes, that are assigned to Tier 1 in their proposed three-tier approach, was proposed (Tsong, Dong, and Shen, 2016). Food and Drug Administration (FDA) has recommended the proposed equivalence testing approach to sponsors through meeting comments for Pre-Investigational New Drug Applications (PINDs) and Investigational New Drug Applications (INDs) since 2014. FDA has received some feedbacks on statistical issues of potentially correlated reference lot values subjected to the equivalence testing since independent and identical observations (lot values) from the proposed biosimilar product and the reference product are assumed...
December 1, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27885553/biosimilars-for-the-treatment-of-chronic-inflammatory-diseases-a-systematic-review-of-published-evidence
#3
REVIEW
Ira Jacobs, Danielle Petersel, Leah Isakov, Sadiq Lula, K Lea Sewell
BACKGROUND: Clinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications. OBJECTIVES: The objective of this study was to systematically collate all published data in order to assess the weight (quantity and quality) of available evidence for each molecule and inform and support healthcare decision-making in chronic inflammatory diseases. METHODS: MEDLINE(®), EMBASE(®), and ISI Web of Science(®) were searched to September 2015...
December 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27881284/perceived-risks-contra-benefits-of-using-biosimilar-drugs-in-ulcerative-colitis-discrete-choice-experiment-among-gastroenterologists
#4
Petra Baji, László Gulácsi, Petra A Golovics, Barbara D Lovász, Márta Péntek, Valentin Brodszky, Fanni Rencz, Péter L Lakatos
BACKGROUND: In middle-income countries, access to biological therapy is limited in ulcerative colitis in terms of the number of patients and the length of therapy. Because of their cost advantages, biosimilars have the potential to improve access to therapy, but physicians have concerns toward their use because of the lack of evidence from randomized clinical trials. OBJECTIVES: To explore the preferences of gastroenterologists for biosimilar drugs in ulcerative colitis as well as to compare our results with results of previous studies on gastroenterologists' preferences toward biosimilars...
September 2016: Value in Health Regional Issues
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#5
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
November 19, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27860290/predictive-glycoengineering-of-biosimilars-using-a-markov-chain-glycosylation-model
#6
Philipp N Spahn, Anders H Hansen, Stefan Kol, Bjørn G Voldborg, Nathan E Lewis
Biosimilar drugs must closely resemble the pharmacological attributes of innovator products to ensure safetyand efficacy to obtain regulatory approval. Glycosylation is one critical quality attribute that must be matched, but it is inherently difficult to control due to the complexity of its biogenesis. This usually implies that costly and time-consuming experimentation is required for clone identification and optimization of biosimilar glycosylation. Here, we describe a computational method that utilizes a Markov model of glycosylation to predict optimal glycoengineering strategies to obtain a specific glycosylation profile with desired properties...
November 17, 2016: Biotechnology Journal
https://www.readbyqxmd.com/read/27854156/demonstration-of-physicochemical-and-functional-similarity-between-the-proposed-biosimilar-adalimumab-msb11022-and-humira%C3%A2
#7
Laurent Magnenat, Angelo Palmese, Christèle Fremaux, Fabio D'Amici, Mariagrazia Terlizzese, Mara Rossi, Laurent Chevalet
Biosimilars are biological products that are highly similar to existing products approved by health authorities. Demonstration of similarity starts with the comprehensive analysis of the reference product and its proposed biosimilar at the physicochemical and functional levels. Here, we report the results of a comparative analysis of a proposed biosimilar adalimumab MSB11022 and its reference product, Humira®. Three batches of MSB11022 and up to 23 batches of Humira® were analyzed by a set of state-of-the-art orthogonal methods...
November 17, 2016: MAbs
https://www.readbyqxmd.com/read/27848166/rheumatologists-perceptions-of-biosimilar-medicines-prescription-findings-from-a-french-web-based-survey
#8
Morgane Beck, Bruno Michel, Marie-Christine Rybarczyk-Vigouret, Dominique Levêque, Christelle Sordet, Jean Sibilia, Michel Velten
BACKGROUND: Healthcare cost savings are closely linked to prescribers' confidence in and acceptance of the prescription of biosimilar drugs. OBJECTIVES: The aim of this study was to assess the knowledge, experience and opinions of hospital-based and office-based French rheumatologists with regard to biosimilar medicines and to identify the barriers to and possible options to promote their prescription. METHODS: A web-based, self-administered survey was conducted among French rheumatologists from June 8 to August 2, 2015...
December 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27832357/emerging-biologics-in-inflammatory-bowel-disease
#9
REVIEW
Heyson Chi-Hey Chan, Siew Chien Ng
Early biologic therapy is recommended in patients with inflammatory bowel disease and poor prognostic factors and in those refractory to conventional medications. Anti-tumor necrosis factor (anti-TNF) agents are the most commonly used biologic agents. However, some patients may not have an initial response to anti-TNF therapy, and one-third will develop loss of response over time. Anti-TNF drugs can also be associated with side effects. In addition, the use of biologics is currently limited by their cost, especially in developing countries...
November 10, 2016: Journal of Gastroenterology
https://www.readbyqxmd.com/read/27830969/plasmapheresis-therapy-in-combination-with-tnf-%C3%AE-inhibitor-and-dmards-a-multi-target-method-for-treatment-of-rheumatoid-arthritis
#10
Yongjing Cheng, Feng Yang, Cibo Huang, Jia Huang, Qian Wang, Yingjuan Chen, Yingjue Du, Like Zhao, Ming Gao, Fang Wang
OBJECTIVE: To evaluate the effects of a multi-target method involving plasmapheresis therapy combined with tumor necrosis factor (TNF)-α inhibitor and disease-modifying anti-rheumatic drugs (DMARDs) on disease activity parameters in the treatment of active rheumatoid arthritis (RA). METHODS: Sixty-five patients with active RA were divided into 2 groups according to treatment administered: the plasmapheresis combination therapy group (Plasmapheresis combination group; 38 cases), in which patients received plasmapheresis therapy along with a TNF-α inhibitor (recombinant human tumor necrosis factor-Fc; rhTNFR:Fc; Etanercept biosimilars) and DMARDs, and a TNF-α inhibitor therapy group (biological agent group; 27 cases), in which patients received a TNF-α inhibitor and DMARDs...
November 10, 2016: Modern Rheumatology
https://www.readbyqxmd.com/read/27829539/chemotherapy-induced-febrile-neutropenia-prophylaxis-with-biosimilar-filgrastim-in-elderly-versus-non-elderly-cancer-patients-patterns-outcomes-and-determinants-monitor-gcsf-study
#11
Matti Aapro, Carsten Bokemeyer, Heinz Ludwig, Pere Gascón, Mario Boccadoro, Kris Denhaerynck, Michael Gorray, Andriy Krendyukov, Karen MacDonald, Ivo Abraham
BACKGROUND: Myelotoxic chemotherapy is associated with chemotherapy-induced (febrile) neutropenia (CIN/FN). The MONITOR-GCSF study evaluated biosimilar filgrastim (Zarzio®) prophylaxis patterns, associated outcomes, and determinants. We performed stratified analyses comparing elderly and non-elderly patients. METHODS: Comparative (elderly/non-elderly) analysis of demographics and clinical status, prophylaxis, associated CIN/FN outcomes (CIN grade 4 [CIN4], FN, CIN/FN-related hospitalizations and chemodisturbances, composite), and, per hierarchical modeling, determinants thereof evaluated at the patient- and cycle-level...
November 6, 2016: Journal of Geriatric Oncology
https://www.readbyqxmd.com/read/27824045/hybrid-mass-spectrometry-approaches-in-glycoprotein-analysis-and-their-usage-in-scoring-biosimilarity
#12
Yang Yang, Fan Liu, Vojtech Franc, Liem Andhyk Halim, Huub Schellekens, Albert J R Heck
Many biopharmaceutical products exhibit extensive structural micro-heterogeneity due to an array of co-occurring post-translational modifications. These modifications often effect the functionality of the product and therefore need to be characterized in detail. Here, we present an integrative approach, combining two advanced mass spectrometry-based methods, high-resolution native mass spectrometry and middle-down proteomics, to analyse this micro-heterogeneity. Taking human erythropoietin and the human plasma properdin as model systems, we demonstrate that this strategy bridges the gap between peptide- and protein-based mass spectrometry platforms, providing the most complete profiling of glycoproteins...
November 8, 2016: Nature Communications
https://www.readbyqxmd.com/read/27822071/biosimilar-epoetin-for-the-management-of-chemotherapy-induced-anemia-in-elderly-patients
#13
Jean-Emmanuel Kurtz, Pierre Soubeyran, Mauricette Michallet, Elisabeth Luporsi, Hélène Albrand
INTRODUCTION: Chemotherapy-induced anemia (CIA) is a frequent complication among cancer patients, with elderly patients more likely to suffer severe effects. Biosimilar erythropoiesis-stimulating agents lower costs of supportive cancer treatment, and thus are particularly relevant in the elderly cancer population, which is growing rapidly worldwide. The goal of this subanalysis was to compare the tolerability and effectiveness of an epoetin biosimilar for treating CIA in patients <70 years old vs patients ≥70 years old...
2016: OncoTargets and Therapy
https://www.readbyqxmd.com/read/27821391/filgrastim-becomes-biosimilar-test-case-for-hospitals
#14
Kate Traynor
No abstract text is available yet for this article.
November 15, 2016: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/27819248/safety-and-efficacy-of-biosimilars-in-oncology
#15
REVIEW
Huub Schellekens, Josef S Smolen, Mario Dicato, Robert M Rifkin
Biosimilars are considered to be one of the solutions to combat the substantially increasing costs of cancer treatment, and its imminent introduction is expected to expand affordability worldwide. However, biosimilar monoclonal antibodies provide many challenges compared with first-generation biosimilars, growth factors, and hormones, because they have shown only a modest clinical effect, and are often used in combination with other more toxic therapies, making it difficult to design studies that allow appropriate efficacy and safety assessments compared with the original products...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27819246/21st-century-pharmacovigilance-efforts-roles-and-responsibilities
#16
REVIEW
Peter J Pitts, Hervé Le Louet, Yola Moride, Rena M Conti
In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27817152/patient-perceptions-and-preferences-of-two-etanercept-autoinjectors-for-rheumatoid-arthritis-findings-from-a-patient-survey-in-europe
#17
Kunal Thakur, Anna Biberger, Alexandra Handrich, Mourad Farouk Rezk
INTRODUCTION: Benepali(®) was the first etanercept (Enbrel(®)) biosimilar to be approved in the European Union. Both Benepali and Enbrel are available as autoinjector devices. In a recent survey, nurses from France, Germany, Italy, Spain, and the United Kingdom (UK) reported that their patients with rheumatoid arthritis (RA) would prefer the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector. To determine whether patients' perceptions were similar to those of the nurses, this survey evaluated patients' perceptions and preferences of the Benepali autoinjector versus the Enbrel MYCLIC autoinjector in the same five European countries...
December 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27813877/biosimilars-the-us-regulatory-framework
#18
Leah A Christl, Janet Woodcock, Steven Kozlowski
With the passage of the Biologics Price Competition and Innovation Act of 2009, the US Food and Drug Administration established an abbreviated pathway for developing and licensing biosimilar and interchangeable biological products. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a "totality of the evidence" that a proposed product is biosimilar to its reference product. By integrating analytical, pharmacological, and clinical data, each of which has limitations, a high level of confidence can be reached regarding clinical performance...
October 28, 2016: Annual Review of Medicine
https://www.readbyqxmd.com/read/27813422/bioequivalence-safety-and-immunogenicity-of-bi-695501-an-adalimumab-biosimilar-candidate-compared-with-the-reference-biologic-in-a-randomized-double-blind-active-comparator-phase-i-clinical-study-voltaire%C3%A2-pk-in-healthy-subjects
#19
Christopher Wynne, Mario Altendorfer, Ivo Sonderegger, Lien Gheyle, Rod Ellis-Pegler, Susanne Buschke, Benjamin Lang, Deepak Assudani, Sandeep Athalye, Niklas Czeloth
Background This Phase I study (VOLTAIRE™-PK) aimed to evaluate three-way pharmacokinetic similarity (bioequivalence), safety and immunogenicity of BI 695501 (a Humira® [adalimumab] biosimilar candidate) compared with US- and EU-approved Humira in healthy male subjects. Methods Subjects (N = 327) were randomized 1:1:1 to receive one 40 mg subcutaneous dose of BI 695501, US- or EU-approved Humira; safety was assessed for 70 days. Bioequivalence was evaluated using the average bioequivalence method to test if the 90% confidence intervals (CIs) of the geometric means (BI 695501 versus US- and EU-approved Humira) for the primary endpoints were within pre-specified acceptance ranges (80-125%)...
November 4, 2016: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/27809913/long-term-safety-and-efficacy-of-omnitrope%C3%A2-a-somatropin-biosimilar-in-children-requiring-growth-hormone-treatment-italian-interim-analysis-of-the-patro-children-study
#20
Lorenzo Iughetti, Gianluca Tornese, Maria Elisabeth Street, Flavia Napoli, Claudia Giavoli, Franco Antoniazzi, Stefano Stagi, Caterina Luongo, Sara Azzolini, Letizia Ragusa, Gianni Bona, Clara Zecchino, Tommaso Aversa, Luca Persani, Laura Guazzarotti, Emiliano Zecchi, Alberto Pietropoli, Stefano Zucchini
BACKGROUND: PATRO Children is an ongoing observational, longitudinal, non-interventional, global post-marketing surveillance study, which is investigating the long-term safety and effectiveness of Omnitrope®, a somatropin biosimilar to Genotropin®, in children with growth disturbances. The primary endpoint of PATRO Children is long-term safety and the secondary endpoint is effectiveness, which is assessed by analysing auxological data such as height (HSDS) and height velocity (HVSDS) standard deviation scores...
November 3, 2016: Italian Journal of Pediatrics
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