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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
#1
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...
2017: 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
#2
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...
February 16, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28192016/new-insulins-biosimilars-and-insulin-therapy
#3
Thomas Danne, Lutz Heinemann, Jan Bolinder
No abstract text is available yet for this article.
February 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28161880/long-term-safety-and-efficacy-of-omnitrope-%C3%A2-in-adults-with-growth-hormone-deficiency-italian-interim-analysis-of-the-patro-adults-study
#4
D Ferone, E Profka, V Gasco, M R Ambrosio, A Colao, C Di Somma, E Puxeddu, G Arnaldi, C Pagano, E Zecchi, A Pietropoli, P Beck-Peccoz
PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope(®), a somatropin biosimilar to Genotropin(®), in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope(®), which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels...
February 4, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28118050/administration-of-biosimilar-insulin-analogs-role-of-devices
#5
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/27750344/-practical-aspects-in-the-use-of-biosimilar-insulins
#6
REVIEW
Irene Krämer, Matthias Blüher, Martin K Kuhlmann, Lutz Heinemann
Following the market authorization of the first insulin biosimilar in 2014, further approvals are to be expected due to patent expiry of several originator insulins. Knowledge of the manufacturing and the characteristics of these pharmaceutical products is important for their rationale and safe use by the physician, the pharmacist and the patient.Biosimilars are not generics, but similar or comparable, yet not identical versions of the originator biopharmaceutical. Marketing authorization in the EU is granted only after passing a stringent procedure...
October 2016: Deutsche Medizinische Wochenschrift
https://www.readbyqxmd.com/read/27574370/the-future-of-biosimilar-insulins
#7
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
#8
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/27381029/if-pbms-guard-access-to-drugs-then-quis-custodiet-ipsos-custodies-who-will-guard-the-guardians
#9
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/27366730/biosimilar-insulins-an-unavoidable-option-in-south-east-asia
#10
Prashant Ulhas Kaduskar
No abstract text is available yet for this article.
July 2016: Indian Journal of Endocrinology and Metabolism
https://www.readbyqxmd.com/read/27364374/insulin-therapy-new-directions-of-research
#11
Edyta Cichocka, Anna Wietchy, Katarzyna Nabrdalik, Janusz Gumprecht
Insulin therapy is the most effective method of lowering blood glucose. Over 100 years have passed the studies for the optimisation of insulin action. To date, subcutaneous insulin administration has been the basic route of insulin delivery. The search for insulin therapy is simultaneously conducted in the following directions: the optimisation of insulin action, automatisation, and the decrease in the invasiveness of insulin delivery methods. The optimisation of insulin action has led to the discovery of ultra-rapid-acting human insulin analogues, ultra-long-acting human insulin analogues, and biosimilar insulin...
2016: Endokrynologia Polska
https://www.readbyqxmd.com/read/27290782/coming-soon-to-a-pharmacy-near-you
#12
Wil Dubois
Recent FDA approvals introduce both cheaper insulin in the form of a biosimilar and lipid-lowering agents with prices that rival the cost of cancer drugs. They also give us brand new ways to lower blood glucose and repair the damage done when glucose control fails. Hundreds more are in the pipeline, of which one or two per year will win marketing approval from the FDA.
May 2016: Diabetes Self-management
https://www.readbyqxmd.com/read/27097592/interchangeability-among-reference-insulin-analogues-and-their-biosimilars-regulatory-framework-study-design-and-clinical-implications
#13
REVIEW
H A Dowlat, M K Kuhlmann, H Khatami, F J Ampudia-Blasco
Biosimilars are regulated differently from small-molecule generic, chemically derived medicines. The complexity of biological products means that small changes in manufacturing or formulation may result in changes in efficacy and safety of the final product. In the face of this complexity, the regulatory landscape for biosimilars continues to evolve, and global harmonization regarding requirements is currently lacking. It is essential that clinicians and patients are reassured that biosimilars are equally safe and effective as their reference product, and this is particularly important when interchangeability, defined as 'changing one medicine for another one which is expected to achieve the same clinical effect in a given clinical setting in any one patient', is considered...
August 2016: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27044370/monitoring-quality-of-biotherapeutic-products-using-multivariate-data-analysis
#14
REVIEW
Anurag S Rathore, Mili Pathak, Renu Jain, Gaurav Pratap Singh Jadaun
Monitoring the quality of pharmaceutical products is a global challenge, heightened by the implications of letting subquality drugs come to the market on public safety. Regulatory agencies do their due diligence at the time of approval as per their prescribed regulations. However, product quality needs to be monitored post-approval as well to ensure patient safety throughout the product life cycle. This is particularly complicated for biotechnology-based therapeutics where seemingly minor changes in process and/or raw material attributes have been shown to have a significant effect on clinical safety and efficacy of the product...
2016: AAPS Journal
https://www.readbyqxmd.com/read/26989067/quality-control-of-insulins-and-biosimilar-insulins-what-do-we-know
#15
EDITORIAL
Alan W Carter, Lutz Heinemann, David C Klonoff
No abstract text is available yet for this article.
July 2016: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/26904463/biosimilar-insulins-informed-choice-for-south-asia
#16
Sanjay Kalra, A K Azad Khan, Syed Abbas Raza, Noel Somasundaram, Dina Shrestha, Zafar Ahmed Latif, Sarita Bajaj, Md Faruque Pathan, Rakesh Sahay, Hajera Mahtab
No abstract text is available yet for this article.
January 2016: Indian Journal of Endocrinology and Metabolism
https://www.readbyqxmd.com/read/26857998/constraints-and-challenges-in-access-to-insulin-a-global-perspective
#17
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/26836429/new-insulins-biosimilars-and-insulin-therapy
#18
REVIEW
Thomas Danne, Lutz Heinemann, Jan Bolinder
No abstract text is available yet for this article.
February 2016: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/26817993/in-the-biosimilar-marketplace-will-there-be-50-ways-to-leave-your-insulin
#19
Alan W Carter
The future biosimilar insulin marketplace could be a bane, benefit, or something in between, to patients under our care in the United States. Formulary preferred product status, with or without FDA interchangeability designation, coupled with current and proposed state pharmacy substitution laws may lead to an environment with as many as 50 different substitution guidelines depending on in which state a patient presents his or her prescription to be filled. If online global prescription supply options, often referred to as "Canada Drug," are utilized, other country substitution guidelines come into play, which may yield a recipe for confusion, if not disaster...
September 2016: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/26604278/how-to-accurately-establish-pharmacokinetics-pharmacodynamics-of-long-acting-insulins-in-humans-relevance-to-biosimilar-insulins
#20
COMMENT
Francesca Porcellati, Paola Lucidi, Geremia B Bolli, Carmine G Fanelli
No abstract text is available yet for this article.
December 2015: Diabetes Care
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