The First Interchangeable Biosimilar Insulin: Insulin Glargine-yfgn

2021 ◽  
pp. 193229682110675
Author(s):  
Mark C. Matli ◽  
Andrea B. Wilson ◽  
Leah M. Rappsilber ◽  
Farron P. Sheffield ◽  
Miranda L. Farlow ◽  
...  
Keyword(s):  
Insulin Glargine ◽  
Price Competition ◽  
Market Competition ◽  
List Price ◽  
Access To Treatment ◽  
State Laws ◽  
Glucose Levels ◽  
Treatment Providers ◽  
Treatment Of Diabetes ◽  
In Suit

On March 23, 2020, all insulin products were reclassified as biologics instead of drugs under the Biological Price Competition and Innovation (BPCI) Act of 2009. This allows biosimilar insulin products to be manufactured when the patent expires for the reference biologic, sometimes called the originator or brand name product. A biosimilar product may not be substituted for the reference biologic at the pharmacy counter unless the biosimilar undergoes further switch trials to earn the designation as an interchangeable biosimilar. Insulin glargine-yfgn 100 units/mL is the first biosimilar insulin to attain interchangeable status with the reference insulin glargine. In the INSTRIDE 1 and INSTRIDE 2 trials, insulin glargine-yfgn has proven noninferiority regarding blood glucose reduction and adverse effect profile versus reference insulin glargine; even in the INSTRIDE 3 trial in which treatment of diabetes was switched between insulin glargine-yfgn and reference insulin glargine throughout the trial without statistically significant changes to glucose levels or adverse effects. Insulin glargine-yfgn may be substituted at the pharmacy counter without consultation with the prescriber, in accordance with state laws. In suit with other biosimilars, insulin glargine-yfgn’s list price is significantly lower than other insulin glargine products. This increases market competition leading to decreases in costs of other insulin glargine products. Many patients who could not previously afford insulin therapy may now have significantly improved access to treatment. Providers will need education to increase awareness of these new biosimilars and interchangeable biosimilar insulin products, cost benefits, and substitution allowances.

The Role of Law in Health Services Delivery: Diabetes and State-Mandated Benefits

2003 ◽  
Vol 31 (S4) ◽  
pp. 51-51 ◽  
Author(s):  
DeKeely Hartsfield ◽  
Frank Vinicor
Keyword(s):  
Systemic Disease ◽  
Insurance Coverage ◽  
Health Insurance Coverage ◽  
Lifestyle Changes ◽  
Standards Of Care ◽  
State Laws ◽  
Glucose Levels ◽  
Services Delivery ◽  
Mandated Benefits ◽  
Control And Prevention

Diabetes is a chronic and systemic disease that has reached epidemic proportions. An estimated 17 million Americans have diabetes (5.9 million of which are undiagnosed), and an additional 16 million individuals are considered to have pre-diabetes. Studies have shown that timely screening and referral are necessary to maintain healthy blood glucose levels and slow the progression of diabetes-related complications. Furthermore, lifestyle changes (i.e., altered diet and physical activity) can prevent or delay the onset of Type 2 diabetes for high-risk individuals.The Division of Diabetes Translation at the Centers for Disease Control and Prevention undertook an analysis of diabetes-related legislation across the nation. More specifically, state laws, rules and regulations mandating health insurance coverage for diabetes-related supplies and services were examined according to Sample Purchasing Specifications for Services Related to Diabetes—an evidence-based model of standards of care for persons with diabetes.

scholarly journals Study on the prescribing pattern of anti-diabetic drugs in community clinic in Uttar Pradesh state

2017 ◽  
Vol 4 (4) ◽  
pp. 207
Author(s):  
Suresh Chandra ◽  
Mohd. Adil Khan ◽  
Anand Mohan
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Study ◽  
Uttar Pradesh ◽  
Postprandial Glucose ◽  
Prescribing Pattern ◽  
Community Clinic ◽  
Glucose Levels ◽  
Drug Of Choice ◽  
Poor Patient Compliance ◽  
Treatment Of Diabetes

Objective: The diabetes mellitus is most common diseases. Which are spread all over the world. At they  are change in modified in life style disease  in this study where the prescribe drugs while using in the diagnostic and treatment of diabetes mellitus .the most commonly use drugs Sitagliptin +Metfomin in the community clinic in U.P. In the survey which are found to be the prescription pattern in Jajmau (Kanpur, U.P.) areas the most common drug which are running Sitagliptin + Metformin the survey which are randomly collect the prescription there are many variation in prescribing pattern of diabetes mellitus .the prescribing pattern is most strong tools to role of drug use in the society which are treat the DM during medication follow the proscription pattern of the drugs. There is need for appropriate safe &effective treatment and economical study to find out the pattern of drug therapy among DM.Methods: In this study the method randomized and non randomized study design was conducted in October 2016 – November 2016 community clinic in U.P. this study found to the date which group gender in fasting blood sugar various classes of drugs analyzed them.Results: A total of 200 patients were included in this one month’s study. All the patients had Type 2 diabetes. Metformin is the drug of choice and Sitagliptin is the most preferred combination with Metformin.Conclusions:Insulin was not preferred as mono-therapy. Despite combination therapy, the postprandial glucose levels were not in range–suggesting either poor patient compliance or inadequate dosing/inappropriate therapy. In addition to drugs, the services of a clinical pharmacist might be helpful in these patients. Metformin is the drug of choice and Sitagliptin is the most preferred combination with Metformin. 

Hypoglycaemia in the treatment of diabetes mellitus

2011 ◽  
pp. 1849-1861
Author(s):  
Pratik Choudhary ◽  
Stephanie A. Amiel
Keyword(s):  
Diabetes Mellitus ◽  
Blood Glucose ◽  
Blood Glucose Concentration ◽  
Cerebral Metabolism ◽  
Chronic Complications ◽  
Glucose Levels ◽  
Patients With Diabetes ◽  
Treatment Of Diabetes ◽  
Clinically Significant ◽  
The Brain

Hypoglycaemia (low blood glucose concentration) is the most important acute complication of the pharmacological treatment of diabetes mellitus. Low blood glucose impairs brain (and, potentially, cardiac) function. The brain has minimal endogenous stores of energy, with small amounts of glycogen in astroglial cells. The brain is therefore largely dependent on circulating glucose as the substrate to fuel cerebral metabolism and support cognitive performance. If blood glucose levels fall sufficiently, cognitive dysfunction is inevitable. In health, efficient glucose sensing and counterregulatory mechanisms exist to prevent clinically significant hypoglycaemia. These are impaired by diabetes and by its therapies. Patients with diabetes rank fear of hypoglycaemia as highly as fear of chronic complications such as nephropathy or retinopathy (1). Fear of hypoglycaemia, hypoglycaemia itself and attempts to avoid hypoglycaemia limit the degree to which glycaemic control can be intensified to reduce the risk of chronic complications of diabetes both for type 1 and type 2 diabetes.

scholarly journals Nocturnal Glycemic Control with New Insulin Glargine 300 U/mL

2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
Neng Chun Yu
Keyword(s):  
Blood Glucose ◽  
Insulin Glargine ◽  
Insulin Therapy ◽  
Real World ◽  
Statistical Significance ◽  
Treatment Phase ◽  
Glycemic Variability ◽  
The Real ◽  
Nocturnal Hypoglycemia ◽  
Glucose Levels

Insulin glargine 300 U/mL (Gla-300) is a new generation basal insulin product that has been demonstrated to have more stable pharmacokinetic and pharmacodynamic characteristics than insulin glargine 100 U/mL (Gla-100). To evaluate the real-world benefits of Gla-300 in reducing nocturnal fluctuations in blood glucose levels and nocturnal hypoglycemia, 10 Taiwanese patients using Gla-100 for insulin therapy were switched to Gla-300 and continuous glucose monitoring (CGM) was applied at nighttime to monitor changes to nocturnal glycemic variability parameters. Glycemic variability parameters measured to assess between- and within-night glycemic variability included mean 6-hour nocturnal (00:00–6:00 AM) glucose levels, standard deviation (SD), and coefficient of variance (CV) of mean nocturnal glucose levels and mean glucose excursion (MAGE). In this study, Gla-300 demonstrated comparable glycemic efficacy to Gla-100 and the potential to further reduce nocturnal hypoglycemia risk. Overall, nocturnal glycemic variability parameters measured during the Gla-300 treatment period were numerically smaller than those measured during the Gla-100 treatment phase although statistical significance was not reached. In terms of within-night glucose management, SD and CV values of mean nocturnal glucose levels were found to be statistically lower during the Gla-300 treatment phase than the Gla-100 treatment phase on nights individuals displayed normal blood glucose level readings at the beginning of the night. In summary, this study represents the first of its kind from Taiwan to evaluate the real-world clinical benefits of switching Taiwanese diabetes patients from Gla-100 to Gla-300 insulin therapy in reducing nighttime glucose variability by means of CGM.

The Legal and Regulatory Status of Biosimilars

2015 ◽  
Vol 41 (1) ◽  
pp. 49-84 ◽  
Author(s):  
Jordan Paradise
Keyword(s):  
Price Competition ◽  
Cost Savings ◽  
The United States ◽  
Current Debate ◽  
New Paradigm ◽  
State Laws ◽  
Patient Protection ◽  
Regulatory Status ◽  
Negative Effect ◽  
Potential Negative Effect

Alongside the constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for “biosimilar” and “interchangeable” biological products. While the current BPCIA implementation debate focuses chiefly on the scope of scientific and technical assessments by the FDA and the effect on the emergent biosimilar industry, two issues will prove essential for determinations of access to and costs of the resulting products: how the biosimilar and interchangeable biosimilar biologics are to be named, and whether pharmacist substitution is appropriate for products the FDA deems interchangeable. This article examines the current debate surrounding the use of nonproprietary names for biosimilar biologics, as well as state efforts to reconcile automatic substitution laws for the eventual products. In particular, the article addresses the implications for patients and the United States health care system, highlighting the potential negative effect on anticipated cost-savings, hindrances for effective tracking and reporting of adverse events, and a general lack of consistency in state laws.

scholarly journals Nocturnal Glucose Metabolism after Bedtime Injection of Insulin Glargine or Neutral Protamine Hagedorn Insulin in Patients with Type 2 Diabetes

2008 ◽  
Vol 93 (10) ◽  
pp. 3839-3846 ◽  
Author(s):  
Thomas Linn ◽  
Britta Fischer ◽  
Nedim Soydan ◽  
Michael Eckhard ◽  
Julia Ehl ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Glargine ◽  
Fasting Blood Glucose ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Nph Insulin ◽  
Double Blind ◽  
Glucose Levels ◽  
Neutral Protamine Hagedorn

Aims/Hypothesis: Insulin glargine is a long-acting human insulin analog often administered at bedtime to patients with type 2 diabetes. It reduces fasting blood glucose levels more efficiently and with less nocturnal hypoglycemic events compared with human neutral protamine Hagedorn (NPH) insulin. Therefore, bedtime injections of insulin glargine and NPH insulin were compared overnight and in the morning. Methods: In 10 type 2 diabetic patients, euglycemic clamps were performed, including [6,6′]2H2 glucose, to study the rate of disappearance (Rd) and endogenous production (EGP) of glucose during the night. On separate days at bedtime (2200 h), patients received a sc injection of insulin glargine, NPH insulin, or saline in a randomized, double-blind fashion. Results: Similar doses of both insulins had different metabolic profiles. NPH insulin had a greater effect on both Rd and EGP in the night compared with insulin glargine. By contrast, in the morning, insulin glargine was more effective, increasing Rd by 5.8 μmol/kg−1·min−1 (95% confidence interval 4.7–6.9) and reducing EGP −5.7 (−5.0 to −6.4) compared with NPH insulin. Nearly 80% of the glucose lowering effect in the morning was due to insulin glargine’s reduction of EGP. Its injection was associated with one-third lower morning glucagon levels compared with NPH insulin (P = 0.021). Conclusion/Interpretation: Nocturnal variations of EGP and Rd explain the reduced incidence of hypoglycemia and lower fasting glucose levels reported for insulin glargine compared with human NPH insulin.

Barriers to Competition and Productivity: Evidence from India

2009 ◽  
Vol 9 (1) ◽  
Author(s):  
Jagadeesh Sivadasan
Keyword(s):  
Price Competition ◽  
Market Competition ◽  
Product Market Competition ◽  
Predominant Role ◽  
Productivity Improvement ◽  
Tariff Rates ◽  
Potential Channels ◽  
Plant Level ◽  
The Impact

Abstract A number of economic theories suggest that barriers to competition lead to higher levels of inefficiency among incumbents. In this paper, we use a detailed plant-level dataset to study the impact on productivity of two reforms (initiated in 1991) aimed at increasing product market competition in India -- liberalization of foreign direct investment (FDI) and reduction in tariff rates. First, we examine the effect of the liberalization policies on mean plant-level productivity in the targeted industries. We find significant increases in productivity in the FDI and tariff-liberalized industries, particularly in the longer term (1993-94). We check and find our results robust to a range of robustness tests. Next, we examine the role of intensive (within-plant productivity growth) and extensive (reallocation from less to more productive plants) margins in the post-reform productivity improvement, and find a predominant role for the former. Finally, we assess potential channels for within-firm productivity improvement. Consistent with a role for price competition, we find evidence of greater declines in output prices as well as concentration measures in the liberalized sectors.

scholarly journals Hypoglucemic Effect Exerted by an Ethynyl-Phenylamino-Steroid-Pyrazole Derivative against Glucose Levels using a Diabetic Model

2021 ◽  
Vol 10 (4) ◽  
pp. 2887-2897
Keyword(s):  
Theoretical Analysis ◽  
Potassium Channel ◽  
Insulin Receptor ◽  
Hypoglycemic Activity ◽  
Pyrazole Derivative ◽  
Similar Form ◽  
Glucose Levels ◽  
Diabetic Model ◽  
Treatment Of Diabetes ◽  
Estrone Derivative

The research aimed to prepare an ethynyl-phenylamino-steroid-pyrazole derivative to evaluate their hypoglycemic activity in a diabetic model using either metformin or glibenclamide as controls. Besides, a theoretical analysis was carried out to evaluate estrone derivative interaction with either insulin receptor (3iga) or potassium channel (3w12). The results showed that steroid derivatives decrease glucose levels, and this effect was in a similar form to metformin. Besides, other data suggest that the ethynyl-phenylamino-steroid-pyrazole derivative could have a higher interaction with the 3iga protein surface compared with metformin. In conclusion, the hypoglycemic activity exerted by the ethynyl-phenylamino-steroid-pyrazole derivative against glucose levels is interesting. In this way, this compound could be a good candidate for the treatment of diabetes.

scholarly journals Self-monitoring of blood glucose as an essential component of exerting total control over diabetes

2014 ◽  
Vol 5 (1) ◽  
pp. 29-33
Author(s):  
E. V Biryukova
Keyword(s):  
Blood Glucose ◽  
Modern Medicine ◽  
Ease Of Use ◽  
Self Monitoring ◽  
Glucose Lowering ◽  
Glucose Levels ◽  
Blood Glucose Levels ◽  
Full Participation ◽  
Treatment Of Diabetes ◽  
Glucose Lowering Therapy

Diabetes mellitus (DM) is a chronic disease associated with the development of micro-and macrovascular complications, prevention of which is an important task of modern medicine. Achieving and maintaining blood glucose levels close to normal, however, is almost impossible without the full participation of the patient in the treatment of diabetes. Self-monitoring of blood glucose (SAG) is the basis of the effectiveness of glucose-lowering therapy and prevention of hypoglycemia. This article discusses the recommended frequency of SCG depending on the type of diabetes. For measuring blood sugar at home now a variety of devices is available. Selection of quality meter is determined by ease of use, ease of operation of the device, ease of preparation and fair presentation of results of the results of measurement.

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