Biosimilar Insulin Glargine Research Articles

Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared With Originator Insulin Glargine (Lantus) in Patients With Type 1 Diabetes After 26 Weeks Treatment

ObjectiveTo compare the immunogenicity, safety, and efficacy of Gan & Lee insulin glargine (GL Glargine) with that of the originator insulin glargine (Lantus) in patients with type 1 diabetes mellitus (T1DM). MethodsThis was a phase 3, multicenter, randomized, open-label, equivalence study. Five hundred seventy-six subjects with T1DM were randomized 1:1 to receive either GL Glargine or Lantus treatment for 26 weeks. The primary end point was the percentage of subjects in each treatment group who developed treatment-induced anti-insulin antibody after baseline and up to visit week 26, which was evaluated using a country-adjusted logistic regression model. The study also compared the changes in glycated hemoglobin, and adverse events including hypoglycemia. ResultsThe percentage of subjects positive for treatment-induced anti-insulin antibody by Week 26 was 25.8% in the GL Glargine treatment group and 25.3% in the Lantus treatment group, with a 90% confidence interval (−5.4, 6.5) of the difference in proportions that fell completely between the similarity margins (−11.3, 11.3). The least squares mean difference between treatment groups for changes in glycated hemoglobin was −0.08 (90% confidence interval: −0.23, 0.06), and the other immunogenicity and safety profiles were comparable. ConclusionGL Glargine demonstrated similar immunogenicity, efficacy, and safety compared to Lantus over 26 weeks in patients with T1DM.

Insulin Access Enhancement in India: Expert Views on Integrating Interchangeable Biosimilar Insulin Glargine.

Achieving and maintaining optimal glycemic targets is the fundamental goal of the management of diabetes. However, failure of oral antidiabetic drugs (OADs) to sustain the targeted glycemic levels in individuals with progressing disease often requires initiation of insulin therapy. This article consolidates the expert opinions of 377 doctors who participated in 34 advisory board meetings held digitally (n=23) and in person (n=11) across India. The present report underscores the need for readily available alternatives, such as biosimilar insulins, in the Indian healthcare market to make insulin accessible to every patient with diabetes. The introduction of biosimilar insulins in the Indian healthcare market is the key to making insulin accessible to every patient with diabetes. Biosimilars are biologic products that closely resemble reference/originator biologics and demonstrate no clinically meaningful differences in safety and effectiveness. The concept of interchangeability serves as a pivotal differentiator for biosimilars, underlining their reliability and safety, and plays a significant role in their broader acceptance and integration into healthcare systems. The 'interchangeability' designation by the United States Food and Drug Administration (USFDA) elevates the biosimilar concept, promoting faster and broader adoption of insulin biosimilars, especially benefiting patients prone to non-adherence to insulin therapy. Healthcare providers are encouraged to consider the option of initiating or transitioning to biosimilar insulin glargine to address the insulin accessibility challenges.

The economic value of insulin glargine 300 U/mL (Gla-300) in people ≥18 years of age with type 2 diabetes mellitus: a value-based economic model from a U.S. payer perspective

AimsThis study aimed to evaluate the value and affordability of insulin glargine 300 U/mL (Gla-300) in a budget impact model from a United States (U.S.) payer perspective by leveraging recent real-world evidence (RWE) studies and incorporating the recent insulin price caps where applicable.Materials and methodsAn economic model for a hypothetical one million U.S. health-plan population was developed to assess the budgetary impact of therapeutic interchanges in either direction between the two long- and longer-acting basal insulins (BIs) for patients with type 2 diabetes over a three-year model horizon. The utilization of long-acting BIs, longer-acting BIs, biosimilar BIs, and insulin degludec (IDeg-100) were informed by IQVIA data and internal forecasting at Sanofi. The DELIVER-2 and DELIVER-naïve studies provided healthcare resource utilization (HCRU) parameters. In the model base case, 24% of patients switched from long-acting BIs to insulin glargine biosimilars, IDeg-100, and other longer-acting BIs (Gla-300) by projected year 3.ResultsThe base case total costs were $10,145 per patient per year (PPPY) in year 3 for the cumulative population. When all patients switched to Gla-300, the total costs in year 3 were $8,799, reflecting a net savings of -$660 PPPY compared to the budget increase of $686 PPPY in the base case. However, the longer-acting to long-acting BIs reversal scenario demonstrated a budgetary decrease of $676 PPPY over the model horizon. The reduction in incremental PPPY cost of $93 was observed using net drug costs rather than wholesale acquisition costs (WAC).LimitationsThe market shares for years 1–3 were based on expectations supported by the clinicians’ expert opinions and were not obtained from real-world data.ConclusionsThe economic value of increased utilization of Gla-300 was driven by the reduction in HCRU, costs and market shares assumptions. Budgetary reductions were achieved by switching patients from long-acting BIs to Gla-300.

Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced reference insulins.

For the successful approval and clinical prescription of insulin biosimilars, it is essential to show pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to the respective reference products sourced from the European Union and the United States. Three phase 1, randomized, double-blind, three-period crossover trials compared single doses of the proposed biosimilar insulin analogues aspart (GL-Asp, n = 36), lispro (GL-Lis, n = 38) and glargine (GL-Gla, n = 113), all manufactured by Gan & Lee pharmaceuticals, to the respective EU- and US-reference products in healthy male participants (GL-Asp and GL-Lis) or people with type 1 diabetes (GL-Gla). Study participants received 0.2 U/kg (aspart and lispro) or 0.5 U/kg (glargine) of each treatment under automated euglycaemic clamp conditions. The clamp duration was 12 h (aspart and lispro) or 30 h (glargine). Primary PK endpoints were the total area under the PK curves (AUCins.total ) and maximum insulin concentrations (Cins.max ). Primary PD endpoints were the total area under the glucose infusion rate curve (AUCGIR.total ) and maximum glucose infusion rate (GIRmax ). Bioequivalence to both EU- and US-reference products were shown for all three GL insulins. Least squares mean ratios for the primary PK/PD endpoints were close to 100%, and both 90% and 95% confidence intervals were within 80%-125% in all three studies. There were no noticeable differences in the safety profiles between test and reference insulins, and no serious adverse events were reported for the GL insulins. GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products.

Biosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know. Insulins perspective

ABSTRACT Introduction For many of the 537 million adults living now with diabetes, the cost of insulin is becoming prohibitive as the insulin prices have tripled between 2002–2013. Globally, the direct annual cost of healthcare expenditure due to diabetes will soon be US$1 Trillion. Biosimilars provide access to high-quality, affordable biologic therapy that is otherwise inaccessible due to the high costs of original biologics. Areas covered A primer to the development of biosimilars shows comparable structural and analytical characterization to the original biologics (e.g. insulins), with no clinically significant or meaningful differences in efficacy and safety. ‘Interchangeability’ status, a regulatory designation by the US FDA, bestowed to some biosimilars, enables confidence in high-quality, bio-equivalent biosimilar of insulin with key global approvals. This can allow rapid uptake of biosimilars by the prescribers, formulary decision-makers, and payors. Biocon-Viatris’s biosimilar Insulin Glargine (Semglee®) is the first interchangeable biosimilar insulin approved by the US FDA. Expert opinion The ‘interchangeable’ status can prompt faster and wider uptake of insulin biosimilars and keep the insulin expenditure under control, especially for patients who otherwise practice non-adherence or rationing of life-saving insulin. Education, support, and awareness can ensure that interchangeable biosimilars gain wider acceptance.

Real-World Impact of Switching From Insulin Glargine (Lantus®) to Basaglar® and Potential Cost Saving in a Large Public Healthcare System in Saudi Arabia.

BackgroundThe advent of Basaglar®, which is a biosimilar insulin glargine formulation for Lantus® has brought hope that it will result in similar outcomes and lower costs. However, some health practitioners raised some concerns about the therapeutic equivalence of this new biosimilar. Therefore, we aimed to examine the clinical and financial impact of switching from Lantus® to Basaglar®.MethodsThis was a single–center retrospective chart review study of adult patients (e.g., ≥18 years) with diabetes mellitus (DM) who were treated with insulin glargine (Lantus®) for at least 12 months and then switched to Basaglar® for another 12 months. The potential cost savings for the years 2018 to 2021 and the cost avoidance for 2022 were estimated using different conversion ratios between the two insulin glargine products (Basaglar® and Lantus®) and acquisition prices.ResultsOne–hundred patients with DM who were previously treated with Lantus® and switched to Basaglar® were retrospectively recruited. About two–thirds of the patients (68%) had type 2 DM, and the male and female patients were equally represented. The mean glycated hemoglobin (A1C) at baseline was 9, and the mean difference in the A1C levels before and after switching to Basaglar® was not significant (0.18, p-value = 0.503, 95% CI [−0.36–0.72]). Although the difference in the total daily insulin units between Lantus® and Basaglar® was not significant, the difference was leaning toward statistical significance despite the small sample size (−1.88, P-value = 0.25, 95% CI [−5.15–1.38]). Switching from Lantus® to Basaglar® could have led to significant cost savings that would range from approximately 1.77 to 23.7 million United States Dollars (USD) for the years 2018 to 2021 assuming an equal conversion ratio. However, those cost savings might not be realized if the switching to Basaglar® required higher daily insulin units, and the difference in the public tender acquisition price between Lantus® and Basaglar® is less than 15%.ConclusionBasaglar® and potentially other biosimilar insulin glargine products can lead to significant cost savings without compromising the quality of care. However, their acquisition prices should be discounted.

The Impact of Mandatory Nonmedical Switching From Originator to Biosimilar Insulin Glargine

PurposeThis study monitors for early changes in health services utilization after a mandatory policy to switch patients from originator to biosimilar insulin glargine in British Columbia, Canada. MethodsWe conducted a prospective cohort study of patients treated with originator insulin glargine. The policy cohort included patients treated with originator insulin glargine in the 6 months before the policy change (May 27, 2019). Three historical control cohorts included users of originator insulin glargine during the 6 months before May 27 each year in 2016, 2017, and 2018. Patients who discontinued or switched use of the originator insulin glargine and those without cost coverage by the provincial drug plan were excluded. Using likelihood ratios, we compared the daily use of medications, outpatient visits, and hospitalizations in the 12 months after the policy change with the daily use in 3 historical control cohorts. A sustained likelihood ratio above a predefined threshold of 7.1 was interpreted as an early signal of a possible policy impact. FindingsEach cohort included 15,344 to 17,310 patients. In the first year of the policy, we observed increases in (1) insulin glargine use (the cumulative incidence increased by 2.5% compared with the mean of the 3 historical cohorts), (2) oral antidiabetic medication use (increased by 2.8%), and (3) outpatient visits (increased by 1.4%). Likelihood ratios greater than the threshold of 7.1 were detected for these 3 outcomes. ImplicationsWe observed marginal changes in health services utilization without detecting signals of negative health impacts on patients targeted by the British Columbia policy of mandatory switching from originator to biosimilar insulin glargine.

Assessing the Structural and Functional Similarity of Insulin Glargine Biosimilars.

A biosimilar product is expected to exhibit similar safety, efficacy, and quality as that of the approved reference product. Only a few reports of thorough evaluation of the quality of insulin glargine biosimilars are available in literature. Here, we examine the structural and functional similarity of biosimilars of insulin glargine, the first basal long-acting insulin analogue with respect to its innovator product (Lantus® from Sanofi Aventis). Structural similarity was established using mass spectrometry, chromatographic, and spectroscopic techniques. Stability was compared by performing accelerated thermal stress studies. Functional similarity was established via in vitro assay. Biosimilar 4 exhibited greater content of high molecular weight species (HMWs) (0.80%) and related substances (RS) (0.45±0.06%) vs others (HMWs of 0.04% and RS of 0.17%). Biosimilars 1 and 3 exhibited higher rate of impurity generation (0.78% and 0.73% per week, respectively), as compared with other drug products (0.02% to 0.43% per week). Furthermore, %aggregation at 14 days was found to statistically correlate (R2= 0.99, root mean square error (RMSE) = 0.095) with %aggregation at 0 day (linearly) and the number of months from expiry (nonlinearly), highlighting the overpowering impact of the latter. While an overall structural and functional similarity was observed across insulin glargine biosimilars with respect to the innovator product, low amounts of product-related variants were seen in some biosimilars and these impact product stability. The %aggregation at 14 days exhibits statistical correlation with %aggregation at 0 day and the number of months from expiry. The order of biosimilarity was denoted as Lantus®>Biosimilar 2>Biosimilar 4>Biosimilar 1>Biosimilar 3.

Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications.

Background Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology. Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel. Results Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups. Conclusions There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed.

Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies

BackgroundMYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes in 2 phase 3 trials. Immunogenicity of MYL-1501D and reference insulin glargine was examined in both studies.MethodsINSTRIDE 1 and INSTRIDE 2 were multicenter, open-label, randomized, parallel-group studies. In INSTRIDE 1, patients with type 1 diabetes received MYL-1501D or insulin glargine over a 52-week period. In INSTRIDE 2, patients with type 2 diabetes treated with oral antidiabetic drugs, insulin naive or not, received MYL-1501D or reference insulin glargine over a 24-week period. Incidence rates and change from baseline in relative levels of antidrug antibodies (ADA) and anti–host cell protein (anti-HCP) antibodies in both treatment groups were determined by a radioimmunoprecipitation assay and a bridging immunoassay, respectively. Results were analyzed using a mixed-effects model (INSTRIDE 1) or a nonparametric Wilcoxon rank sum test (INSTRIDE 2).ResultsTotal enrollment was 558 patients in INSTRIDE 1 and 560 patients in INSTRIDE 2. The incidence of total and cross-reactive ADA was comparable between treatment groups in INSTRIDE 1 and INSTRIDE 2 (P > 0.05 for both). A similar proportion of patients had anti-HCP antibodies in both treatment groups in INSTRIDE 1 at week 52 (MYL-1501D, 93.9 %; reference insulin glargine, 89.6 %; P = 0.213) and in INSTRIDE 2 at week 24 (MYL-1501D, 87.3 %; reference insulin glargine, 86.9 %; P > 0.999).ConclusionsIn INSTRIDE 1 and INSTRIDE 2, similar immunogenicity profiles were observed for MYL-1501D and reference insulin glargine in patients with type 1 diabetes and type 2 diabetes, respectively.Trial registrationClinicalTrials.gov, INSTRIDE 1 (NCT02227862; date of registration, August 28, 2014); INSTRIDE 2 (NCT02227875; date of registration, August 28, 2014).

The Current Situation Regarding Long-Acting Insulin Analogues Including Biosimilars Among African, Asian, European, and South American Countries; Findings and Implications for the Future.

Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers.Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders.Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries.Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production.Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities.

Physicochemical and functional characterization of MYL-1501D, a proposed biosimilar to insulin glargine.

Insulin glargine is a long-acting analogue of human insulin that has been used to manage hyperglycemia in patients with diabetes mellitus (DM) for nearly 20 years. Insulin glargine has a relatively constant concentration-time profile that mimics basal levels of insulin and allows for once-daily administration. MYL-1501D is a biosimilar insulin glargine designed to offer greater access of insulin glargine to patients, with comparable efficacy and safety to the marketed reference product. We conducted a comprehensive panel of studies based on a formal analysis of critical quality attributes to characterize the structural and functional properties of MYL-1501D and reference insulin glargine products available in the United States and European Union. MYL-1501D was comprehensively shown to have high similarity to the reference products in terms of protein structure, metabolic activity (both in vitro cell-based assays and in vivo rabbit bioassays), and in vitro cell-based assays for mitogenic activity. The structural analyses demonstrated that the primary protein sequence was identical, and secondary and tertiary structures are similar between the proposed biosimilar and the reference products. Insulin receptor binding affinity and phosphorylation studies also established analytical similarity. MYL-1501D demonstrated high similarity in different metabolic assays of glucose uptake, adipogenesis activity, and inhibition of stimulated lipolysis. Rabbit bioassay studies showed MYL-1501D and EU-approved insulin glargine are highly similar to US-licensed insulin glargine. These product quality studies show high similarity between MYL-1501D and licensed or approved insulin glargine products and suggest the potential of MYL-1501D as an alternative cost-effective treatment option for patients and clinicians.

Ongoing efforts to improve the management of patients with diabetes in Bangladesh and the implications

ABSTRACT Background Prevalence rates of patients with diabetes are growing across countries, and Bangladesh is no exception. Associated costs are also increasing, driven by costs associated with the complications of diabetes including hypoglycemia. Long-acting insulin analogues were developed to reduce hypoglycemia as well as improve patient comfort and adherence. However, they have been appreciably more expensive, reducing their affordability and use. Biosimilars offer a way forward. Consequently, there is a need to document current prescribing and dispensing rates for long-acting insulin analogues across Bangladesh, including current prices and differences, as a result of affordability and other issues. Methods Mixed method approach including surveying prescribing practices in hospitals coupled with dispensing practices and prices among community pharmacies and drug stores across Bangladesh. This method was adopted since public hospitals only dispense insulins such as soluble insulins free-of-charge until funds run out and all long-acting insulin analogues have to be purchased from community stores. Results There has been growing prescribing and dispensing of long-acting insulins in Bangladesh in recent years, now accounting for over 80% of all insulins dispensed in a minority of stores. This increase has been helped by growing prescribing and dispensing of biosimilar insulin glargine at lower costs than the originator, with this trend likely to continue with envisaged growth in the number of patients. Consequently, Bangladesh can serve as an exemplar to other low- and middle-income countries struggling to fund long-acting insulin analogues for their patients. Conclusions It was encouraging to see continued growth in the prescribing and dispensing of long-acting insulin analogues in Bangladesh via the increasing availability of biosimilars. This is likely to continue benefitting all key stakeholder groups.

Treatment satisfaction, safety, and effectiveness of biosimilar insulin glargine is comparable in patients with type 2 diabetes mellitus after switching from insulin glargine or insulin degludec: a post-marketing safety study

Objective To evaluate insulin treatment satisfaction, safety, and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice for Japanese patients with type 2 diabetes mellitus (T2DM) who switched from originator insulin glargine (100 U/mL) or insulin degludec treatment to GLY treatment. Methods The Insulin Treatment Satisfaction Questionnaire (ITSQ) was used to assess treatment satisfaction in a subgroup analysis of a post-marketing safety study. Hypoglycemia incidence rates and blood glucose control are also reported during the 12-month observation period for GLY-switched patients. Results Of 1104 patients with T2DM enrolled to participate, 565 patients switched from either insulin glargine U100/mL (n = 470) or insulin degludec (n = 95) to GLY. The mean total change from baseline to 3 months for total ITSQ score was 1.35 (95% confidence interval [CI] − 0.13 to 2.83, p = .073) for patients who switched from insulin glargine and 2.63 (95% CI −1.43 to 6.70, p = .195) for patients who switched from insulin degludec to GLY treatment. The mean change from baseline to 12 months in hypoglycemia events reported per month was −0.04% (95% CI −0.12 to 0.03, p = .236) for patients who switched from insulin glargine and no change for patients who switched from insulin degludec (0.00, 95% CI −0.20 to 0.20, p = 1.000). Non-significant mean changes from baseline to 12 months were observed for hemoglobin A1c and fasting plasma glucose in GLY-switched patients. Conclusions Treatment satisfaction does not change significantly in Japanese patients with T2DM who switch to GLY from the reference product or from insulin degludec. Safety and effectiveness over a 12-month period were similar in GLY-treated patients who switched from either insulin glargine or insulin degludec. ClinicalTrials.gov Not applicable.

Real-World Budget Impact of the Adoption of Insulin Glargine Biosimilars in Primary Care in England (2015-2018).

Lantus, the reference insulin glargine used for the treatment of diabetes, lost its patent protection in 2014, opening the market to biosimilar competitors. First, to analyze the adoption rates of insulin glargine biosimilars in primary care in England and estimate the savings realized and missed, since an insulin glargine biosimilar was first used, and second, to assess potential variations in adoption rates across Clinical Commissioning Groups (CCGs). Data sets capturing information on all insulin glargine items prescribed by all general practitioners up to December 2018 were used. Total costs of insulin glargine and uptake rates of biosimilars were calculated. The real-world budget impact was estimated assuming the cost of reference insulin glargine for all items and comparing the total costs in this scenario with the total costs in the real world. The missed savings were estimated assuming the cost of biosimilars for all insulin glargine items. Choropleth maps were generated to assess potential variations in uptake across CCGs. Insulin glargine biosimilars generated savings of £900,000 between October 2015 (time of first prescription) and December 2018. The missed savings amounted to £25.6 million in this period, indicating that only 3.42% of the potential savings were achieved. The analyses demonstrated a large level of variation in the uptake of insulin glargine biosimilars across CCGs, with market shares ranging from 0 to 53.3% (December 2018). These results may encourage decision makers in England to promote the use of best-value treatments in primary care and to reevaluate variation across CCGs.

Six Months Comparative Evaluation of Efficacy and Safety of Wockhardt's Biosimilar Insulin Glargine (Glaritus®) with Reference Insulin Glargine (Lantus®) in Type 2 Diabetes Mellitus in India: Results of Interim Analysis

Objective: To compare the change in immunogenic response, safety and efficacy of insulin glargine in Glaritus® and Lantus® treatment arms from baseline to six months in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Material and methods: In an ongoing prospective, open-label, randomized, parallel-group, comparative, multicenter, phase IV study, adult patients with uncontrolled T2DM are treated with either Glaritus® once daily or Lantus® once daily for six months, both given subcutaneously. Glaritus® treatment arm is to be continued for another six months. The primary endpoint for the study was the percentage change in anti-insulin antibodies (AIA) titer to glargine in both treatment arms from baseline to six months. Results: Ninety patients were randomized to each group. Baseline characteristics were comparable between the groups (p>0.05). There was no significant difference in percent change in the AIA titer between the two treatment arms at the end of six months in ITT (intent-to-treat) and mITT(modified intent to treat) population (LS mean diff [95% CI]: 2.2% (-15.1%, 19.6%), p=0.7987 and 3.4% (-15.1%, 21.9%), p=0.7181, respectively). No significant between-group difference was seen in change in the HbA1c level at the end of six months in ITT and mITT population [LS mean diff (95% CI): -0.2 (-0.4, 0.0), p=0.1072 for ITT population; and -0.1 (-0.3, 0.1), p=0.2283, for mITT population]. There was also no significant difference between two groups for the incidence of adverse events [Glaritus® 17 (18.9%) and Lantus® 20 (22.2%) p=0.5800]. Conclusion: Glaritus® was found to be non-inferior to Lantus® in glycaemic control and comparable in immunogenic response and safety at the end of six months in patients with T2DM uncontrolled on OADs.

Savings with insulin glargine biosimilars in England could be much higher

Savings with insulin glargine biosimilars in England could be much higher

Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study

Objective: To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice.Methods: This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control.Results: The study enrolled 141 patients with T1DM and 1104 patients with T2DM. Pre-study insulin was used by 94.1% of patients with T1DM and 75.0% with T2DM. 65.4% of patients with T1DM and 64.3% with T2DM switched from the reference product (GLY-switched), while 25.0% with T2DM were insulin-naive. Adverse events were reported by 5.7% and 8.5% in T1DM and T2DM, respectively. Similar incidences were reported in GLY-switched. Adverse events were reported by 10.7% in insulin-naive T2DM. Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was –1.2 (p = .066) and 0.0 (p = .915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was –0.5% (p < .001) and –0.9% (p < .001), respectively, and –1.5% (p < .001) in insulin-naive T2DM.Conclusions: This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice.

The High Cost of Insulin in the United States: An Urgent Call to Action

The High Cost of Insulin in the United States: An Urgent Call to Action

Cost-effectiveness of insulin degludec versus insulin glargine U100 in adults with type 1 and type 2 diabetes mellitus in Bulgaria

BackgroundThis analysis evaluates the cost-effectiveness of insulin degludec (degludec) versus biosimilar insulin glargine U100 (glargine U100) in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM) in Bulgaria.MethodsA simple, short-term model was used to compare the treatment costs and outcomes associated with hypoglycaemic events with degludec versus glargine U100 in patients with T1DM and T2DM from the perspective of the Bulgarian National Health Insurance Fund. Cost-effectiveness was analysed over a 1-year time horizon using data from clinical trials. The incremental cost-effectiveness ratio (ICER) was the main outcome measure.ResultsIn Bulgaria, degludec was highly cost-effective versus glargine U100 in people with T1DM and T2DM. The ICERs were estimated to be 4493.68 BGN/quality-adjusted life year (QALY) in T1DM, 399.11 BGN/QALY in T2DM on basal oral therapy (T2DMBOT) and 7365.22 BGN/QALY in T2DM on basal bolus therapy (T2DMB/B), which are below the cost-effectiveness threshold of 39,619 BGN in Bulgaria. Degludec was associated with higher insulin costs in all three patient groups; however, savings from a reduction in hypoglycaemic events with degludec versus glargine U100 partially offset these costs. Sensitivity analysis demonstrated that the results were robust and largely insensitive to variations in input parameters. At a willingness-to-pay threshold of 39,619 BGN/QALY, the probability of degludec being cost-effective versus glargine U100 was 60.0% in T1DM, 99.4% in T2DMBOT and 91.3% in T2DMB/B.ConclusionDegludec is a cost-effective alternative to biosimilar glargine U100 for patients with T1DM and T2DM in Bulgaria. Degludec could be of particular benefit to those patients suffering recurrent hypoglycaemia and those who require additional flexibility in the dosing of insulin.