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biosimilar diabetes

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
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
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
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...
July 4, 2016: Journal of Diabetes Science and Technology
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
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
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
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
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...
March 2016: Journal of Diabetes Science and Technology
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
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
Jan Škrha
Biosimilar insulins are biological drugs with the effect similar to reference insulins. Documented safety and efficacy are the main demand for their clinical utility. The subsequent introduction into clinical practice will be followed by more frequent use which will need longterm evaluation of their effect on glycemia and eventual side effects as well.
April 2015: Vnitr̆ní Lékar̆ství
Fernando J Lavalle-González, Hootan Khatami
Biosimilar insulins have the potential to increase access to treatment among patients with diabetes mellitus, reduce treatment costs, and expand market competition. The patents for several insulins are soon to expire, meaning there is room for copies of these products--or 'biosimilars'--to join the marketplace. It is vital that similar safety and efficacy to the innovator product is demonstrated for biosimilars. This presents many possible manufacturing and regulatory challenges. Complex manufacturing processes mean that even small differences between manufacturers can have a potential impact on the final product...
October 2014: Postgraduate Medicine
M Alan Menter, Christopher E M Griffiths
The umbrella term psoriasis is now understood to incorporate several distinct phenotypes or endotypes along the disease spectrum that in turn will dictate different therapies. A stratified medicine approach to psoriasis using this clinical information coupled with pharmacogenomic and immunologic data will become more widely acceptable in the future. Comorbidities associated with psoriasis, such as diabetes, depression, and Crohn disease, and the debate about the interdependence of psoriasis and cardiovascular disease will also dictate future research and holistic and management plans for this complex disease...
January 2015: Dermatologic Clinics
Alan J Garber
No abstract text is available yet for this article.
March 2015: Journal of Diabetes
Héctor García-Nares, María Isabel Leyva-Carmona, Neftalí Pérez-Xochipa, Erwin Chiquete
No abstract text is available yet for this article.
March 2015: Journal of Diabetes
Steven Edelman, William H Polonsky, Christopher G Parkin
BACKGROUND: Many branded analog insulins will lose patent protection during the next few years. In response, a number of companies are developing biosimilar insulins, which have the potential to lower healthcare costs and increase patient access. Although these products are not yet available in the US, it is important that patients, payers and clinicians be aware of the potential benefits as well as concerns associated with biosimilar insulins. SCOPE: This report provides information about these new products and discusses key questions clinicians should consider regarding biosimilar insulin...
November 2014: Current Medical Research and Opinion
Ian Blumer, Steven Edelman
Biologic drugs, such as currently prescribed insulins, are large, complex, 3-dimensional molecules manufactured in biological systems. The complexity of the structure of the biologic drug and its manufacturing process means that it is challenging to create a biologic drug that is identical to the original branded drug. With the potential availability on the horizon of follow-on insulin products (also known as biosimilar insulins) in the United States and other countries where they are not currently in use, physicians (and other prescribers) need to be aware of the potential benefits and concerns regarding biosimilar insulins in order to facilitate informed decision making and to provide the best possible advice and guidance to their patients with diabetes...
May 2014: Postgraduate Medicine
David Hutton, Paula Anne Newman-Casey, Mrinalini Tavag, David Zacks, Joshua Stein
The biologic drugs bevacizumab and ranibizumab have revolutionized treatment of diabetic macular edema and neovascular age-related macular degeneration, leading causes of blindness. Ophthalmologic use of these drugs has increased and now accounts for roughly one-sixth of the Medicare Part B drug budget. The two drugs have similar efficacy and potentially minor differences in adverse-event rates; however, at $2,023 per dose, ranibizumab costs forty times more than bevacizumab. Using modeling methods, we predict ten-year (2010-20) population-level costs and health benefits of using bevacizumab and ranibizumab...
June 2014: Health Affairs
Richard O Dolinar, Steve Edelman, Lutz Heinemann, Philip Home, Shefali Goyal, William H Polonsky, Huub Schellekens
The availability of biosimilar insulins can potentially lead to lower insulin costs and increased access for patients with diabetes, worldwide. However, clinicians and regulatory agencies have raised several concerns regarding the safety and efficacy of these new medications. The European regulatory agencies have established guidelines for market approval of biosimilar insulins; however, many issues remain unresolved. Moreover, although the FDA has developed preliminary pathways for biosimilar protein development and is prepared to review each application on a case-by-case basis, insulins do not fall under this pathway at this time...
January 1, 2014: Journal of Diabetes Science and Technology
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