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biosimilar insulin

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
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
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
Prashant Ulhas Kaduskar
No abstract text is available yet for this article.
July 2016: Indian Journal of Endocrinology and Metabolism
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
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
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
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...
July 2016: AAPS Journal
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
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
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
Thomas Danne, Lutz Heinemann, Jan Bolinder
No abstract text is available yet for this article.
February 2016: Diabetes Technology & Therapeutics
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
Francesca Porcellati, Paola Lucidi, Geremia B Bolli, Carmine G Fanelli
No abstract text is available yet for this article.
December 2015: Diabetes Care
Philip Home
No abstract text is available yet for this article.
December 2015: Diabetes Care
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...
September 8, 2015: Journal of Diabetes Science and Technology
Anne L Peters, R Daniel Pollom, Jason S Zielonka, Michelle A Carey, Steven V Edelman
OBJECTIVE: To provide clinicians with an overview of similar biologic products including biosimilars and new insulin versions available in the U.S. and of key issues associated with such products, including differences in manufacturing and regulatory approaches and their impact on clinical use. METHODS: We reviewed the relevant clinical and regulatory literature. RESULTS: Patent protections for many biologics including several insulin preparations have or will expire shortly...
December 2015: Endocrine Practice
Stella Stergiopoulos, Kenneth Getz
Historical studies of voluntary, spontaneous drug reports show poor attribution of adverse events to generic versions of commonly prescribed medications. As biosimilars enter the market place, it may be similarly difficult to accurately attribute adverse events to their respective reference products. At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals...
August 2015: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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