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https://www.readbyqxmd.com/read/28846865/insulin-glargine-and-its-two-active-metabolites-a-sensitive-16pm-and-robust-simultaneous-hybrid-assay-coupling-immunoaffinity-purification-with-lc-ms-ms-to-support-biosimilar-clinical-studies
#1
Yang Xu, Li Sun, Melanie Anderson, Philippe Bélanger, Vincent Trinh, Patricia Lavallée, Bhavna Kantesaria, Marie-Josée Marcoux, Sheila Breidinger, Kevin P Bateman, Dina Goykhman, Eric J Woolf
MK-1293 is a newly approved follow-on/biosimilar insulin glargine for the treatment of Type 1 and Type 2 diabetics. To support pivotal clinical studies during biosimilar evaluation, a sensitive, specific and robust liquid chromatography and tandem mass spectrometry (LC-MS/MS) assay for the simultaneous quantification of glargine and its two active metabolites, M1 and M2 were developed. Strategies to overcome analytical challenges, so as to optimize assay sensitivity and improve ruggedness, were evolved, resulting in a fully validated LC-MS/MS method with a lower limit of quantification (LLOQ) at 0...
August 19, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28722480/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-1-diabetes-also-using-insulin-glargine-sorella-1-study
#2
Satish K Garg, Karin Wernicke-Panten, Maria Rojeski, Suzanne Pierre, Yvonne Kirchhein, Krystyna Jedynasty
BACKGROUND: SAR342434 is a biosimilar follow-on of insulin lispro-Humalog(®). This study aimed to show similar efficacy, safety, and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin glargine (Lantus(®); GLA-100). MATERIALS AND METHODS: SORELLA-1 was a randomized, open-label phase 3 study (NCT02273180). Patients completing the 6-month main study continued on SAR-Lis or Ly-Lis, as randomized, for a 6-month safety extension...
August 30, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28608570/introduction-of-biosimilar-insulins-in-europe
#3
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/28588966/challenges-constraining-access-to-insulin-in-the-private-sector-market-of-delhi-india
#4
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/28458515/united-states-experience-of-insulin-degludec-alone-or-in-combination-for-type-1-and-type-2-diabetes
#5
REVIEW
Marc Rendell
Insulin degludec has been the product of a sophisticated and systematic biochemical engineering program which began with the release of insulin detemir. The goal was to produce a long-lasting basal insulin with low individual variability. Certainly, this goal has been achieved. Degludec has a duration of action approaching twice that of glargine. Another advantage of degludec is in its lack of unpredictable copolymerization of added aspart. In several studies, degludec has shown lower rates of nocturnal hypoglycemia than glargine...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28371461/comparison-of-morning-basal-1-bolus-insulin-therapy-insulin-glulisine-insulin-glargine-300-u-ml-vs-insulin-lispro-insulin-glargine-biosimilar-using-continuous-glucose-monitoring-a-randomized-crossover-study
#6
Soichi Takeishi, Hiroki Tsuboi, Shodo Takekoshi
INTRODUCTION: We compared the effects of morning administration of insulin glulisine + insulin glargine 300 U/mL (G + G300) with that of insulin lispro + insulin glargine biosimilar (L + GB). MATERIALS AND METHODS: A total of 30 patients with type 2 diabetes who wore a continuous glucose monitoring device on admission after glucose levels were stabilized by morning long-acting and ultra-rapid-acting insulins were randomly allocated to groups who received G + G300 on days 1 and 2, and the same dose L + GB on days 3 and 4, or vice versa...
March 28, 2017: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28334539/-long-acting-insulins-in-the-treatment-of-type-2%C3%A2-diabetes-and-their-position-in-the-current-treatment-algorithm
#7
REVIEW
Martin Haluzík
Insulin therapy has been for many years an inseparable part of the treatment of patients with type 2 diabetes, in particular those with longer diabetes duration. Current national and international guidelines list insulin treatment as a possible second choice therapy in patient with unsatisfactory glucose control on monotherapy with metformin. In reality, insulin therapy is often initiated later than it optimally should be. The reasons include among others the fear of patients and sometimes also of physicians from the side effects of insulin...
December 0: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/28210866/cost-effectiveness-of-insulin-degludec-versus-insulin-glargine-in-adults-with-type-1-and-type-2-diabetes-mellitus
#8
Marc Evans, Barrie Chubb, Jens Gundgaard
INTRODUCTION: To estimate the cost-effectiveness of insulin degludec (IDeg) versus insulin glargine U100 (IGlar U100) and new-to-market basal insulin analogues in patients with diabetes in order to aid decision-making in a complex basal insulin market. METHODS: A simple, short-term model was used to evaluate the costs and effects of treatment with IDeg versus IGlar U100 over a 12-month period in patients with type 1 (T1DM) and type 2 diabetes (T2DM) from the perspective of the UK National Health Service...
April 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28118050/administration-of-biosimilar-insulin-analogs-role-of-devices
#9
Lutz Heinemann, Ingo Fritz, Hootan Khatami, Steven V Edelman
With the expiration of patent protection for several originator insulin analog molecules, the availability of insulin analog copies is set to increase. Many regulatory authorities have developed, and continue to refine, guidelines for the approval of biosimilar insulin analogs. Aspects such as the structure, pharmacokinetics and pharmacodynamics, efficacy, safety, and immunogenicity of biosimilar insulin analogs are extensively addressed in these guidelines, but how the biosimilar insulin analog is administered to people with diabetes is not usually a topic...
February 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/27574370/the-future-of-biosimilar-insulins
#10
Anne Park Kim, Ross Jason Bindler
IN BRIEF Biosimilar insulins are available in many countries and will be made available in the United States in the near future. Some concerns associated with biosimilar insulins include potential differences in the efficacy and safety between a biosimilar product and its reference insulin, the ramifications of having the same name or different names for a biosimilar and its reference insulin, the prospects of and limitations to substituting insulin products, and the proper implementation of pharmacovigilance...
August 2016: Diabetes Spectrum: a Publication of the American Diabetes Association
https://www.readbyqxmd.com/read/27565486/-comparison-of-two-insulin-glargine-formulations-biosimilar-vs-reference-product
#11
Elisabeth Mönnig, Nanette Schloot, Cloth Hohberg, Tobias Wiesner, Lutz Heinemann
BACKGROUND: Biosimilar medicinal products have been in use in the European Union since 2006. In September 2014, insulin glargine (LY IGlar) was approved as a long-acting insulin analogue. In accordance with EMA (European Medicines Agency) and FDA (Food and Drug Administration) guidelines, analytical, preclinical and clinical studies were submitted demonstrating drug safety and biosimilarity of LY IGlar with the reference insulin glargine (IGlar). METHOD: In a review article, study data collected in the clinical development of LY IGlar are summarized...
August 2016: MMW Fortschritte der Medizin
https://www.readbyqxmd.com/read/27504068/european-league-against-rheumatism-and-american-diabetes-association
#12
Walter Alexander
We present EULAR sessions on the latest treatments for rheumatic disease with an infliximab biosimilar, certolizumab pegol, secukinumab, and bimekizumab. We also report on significant developments in diabetes presented at ADA's Scientific Sessions.
August 2016: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/27381029/if-pbms-guard-access-to-drugs-then-quis-custodiet-ipsos-custodies-who-will-guard-the-guardians
#13
Alan W Carter, Lutz Heinemann
Insulin prices in the United States have risen dramatically in recent years, yet pharmacies cannot provide a stable price for a given insulin due to factors that are not widely understood. This commentary discusses the complex and obscure factors that drive today's insulin prices with a discussion of the other players, besides the insulin manufacturer, who benefit from higher prices. An open discussion is critical regarding this drug and others that are essential to the lives of millions of people with diabetes...
November 2016: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/27356195/managed-care-aspects-of-psoriasis-and-psoriatic-arthritis
#14
Colby Evans
The chronic and systemic nature of psoriasis has a significant impact on direct costs, indirect costs, and patient quality of life. Psoriasis is associated with comorbid conditions that add to the burden of the disease, especially in moderate to severe disease. The total estimated annual healthcare burden of psoriasis may be as high as $35.2 billion, with $12.2 billion in direct costs and $23 billion in indirect costs (attributed to reduced health-related quality of life and lost productivity). These costs vary based on the severity of the disease; pharmacy costs account for the majority of the burden, especially in severe disease...
June 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/26857998/constraints-and-challenges-in-access-to-insulin-a-global-perspective
#15
REVIEW
David Beran, Margaret Ewen, Richard Laing
Substantial attention has been given to the issue of access to medicines for communicable diseases; however, access to essential medicines for diabetes, especially insulin, has had insufficient focus. Although insulin was discovered in 1921, the drug is unattainable to many globally, and this Review aims to highlight the range and complexity of factors that contribute to this unattainability. Manufacturers' selling prices of various insulin formulations and presentations, duties, taxes, mark-ups, and other supply chain costs affect the price of insulin and hence the drug's affordability to health systems and individuals...
March 2016: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/26697765/treating-to-target-in-established-rheumatoid-arthritis-challenges-and-opportunities-in-an-era-of-novel-targeted-therapies-and-biosimilars
#16
REVIEW
Thasia G Woodworth, Alfons A den Broeder
There is increasing consensus that periodic monitoring of disease activity status in rheumatoid arthritis (RA) patients to achieve and maintain remission, or at least low disease activity (LDA), the so-called treat to target (T2T) improves outcomes regardless of the duration of disease. Based on systematic literature reviews (SLRs) of clinical trials and registries, International Recommendations published in 2015 represent expert opinion describing efficacy and safety of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and biologic DMARDs (bDMARDs)...
August 2015: Best Practice & Research. Clinical Rheumatology
https://www.readbyqxmd.com/read/26509843/the-past-present-and-future-of-basal-insulins
#17
REVIEW
Jeremy Pettus, Tricia Santos Cavaiola, William V Tamborlane, Steven Edelman
Insulin production by the pancreas follows a basic pattern where basal levels of insulin are secreted during fasting periods, with prandial increases in insulin associated with food ingestion. The aim of insulin therapy in patients with diabetes is to match the endogenous pattern of insulin secretion as closely as possible without causing hypoglycaemia. There are several optimal pharmacokinetic and pharmacodynamic properties of long-acting basal insulins that can help to achieve this aim, namely, as follows: activity that is flat and as free of peaks as possible, a duration of action of ≥24-h, and as little day-to-day variation as possible...
September 2016: Diabetes/metabolism Research and Reviews
https://www.readbyqxmd.com/read/26350722/biosimilar-insulin-and-costs-what-can-we-expect
#18
Lutz Heinemann
The costs for insulin treatment are high, and the steady increase in the number of patients with diabetes on insulin presents a true challenge to health care systems. Therefore, all measures to lower these costs are welcomed by patients, physicians, and health care providers. The market introduction of biosimilar insulins presents an option to lower treatment costs as biosimilars are usually offered at a lower price than the originator product. However, the assumption that a drastic reduction in insulin prices will take place, as was observed with many generic drugs, is most probably not realistic...
September 8, 2015: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/25990669/the-advent-of-biosimilars-for-the-treatment-of-diabetes-current-status-and-future-directions
#19
REVIEW
Giovanni Polimeni, Gianluca Trifirò, Ylenia Ingrasciotta, Achille P Caputi
Biosimilar insulins are likely to enter the market of diabetes therapies as patents for major branded insulin products start to expire in the next few years (on June 2014, the European Medicines Agency authorized the first biosimilar of insulin glargine, Abasria, 100 Units/ml, for the treatment of diabetes mellitus). This would allow providing comparable clinical benefits of the current available insulins at a significantly lower cost, thus increasing the affordability and access of insulin treatment for patients with diabetes...
June 2015: Acta Diabetologica
https://www.readbyqxmd.com/read/25974131/biosimilar-insulins-guidance-for-data-interpretation-by-clinicians-and-users
#20
REVIEW
L Heinemann, P D Home, M Hompesch
Biosimilar insulins are approved copies of insulins outside patent protection. Advantages may include greater market competition and potential cost reduction, but clinicians and users lack a clear perspective on 'biosimilarity' for insulins. The manufacturing processes for biosimilar insulins are manufacturer-specific and, although these are reviewed by regulators there are few public data available to allow independent assessment or review of issues such as intrinsic quality or batch-to-batch variation. Preclinical measures used to assess biosimilarity, such as tissue and cellular studies of metabolic activity, physico-chemical stability and animal studies of pharmacodynamics, pharmacokinetics and immunogenicity may be insufficiently sensitive to differences, and are often not formally published...
October 2015: Diabetes, Obesity & Metabolism
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