Biosimilar vs originator insulins: Systematic review and meta‐analysis

Yamada, Tomohide; Kamata, Ryuichi; Ishinohachi, Kotomi; Shojima, Nobuhiro; Ananiadou, Sophia; Nom, Hisashi; Yamauchi, Toshimasa; Kadowaki, Takashi

doi:10.1111/dom.13291

Cited by 27 publications

(22 citation statements)

References 18 publications

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“…Lack of insulin access precludes optimal diabetes management, and many patients who do have access are burdened by limited healthcare coverage coupled with the high cost of insulin, creating a significant barrier to glycemic control 2,3 .…”

Section: Insulin Access and Economic Burdenmentioning

confidence: 99%

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

Shingaki

Taki

Koyanagi

et al. 2020

Current Medical Research and Opinion

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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 insulinnaive 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 ¼ .066) and 0.0 (p ¼ .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. ARTICLE HISTORY

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Section: Insulin Access and Economic Burdenmentioning

confidence: 99%

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

Shingaki

Taki

Koyanagi

et al. 2020

Current Medical Research and Opinion

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“…Biosimilar insulin glargin 100: Pharmacokinetics and -dynamics are comparable for insulin glargin 100 and biosimilar insulin glargin 100 in humans without and with type 2 diabetes [136,137]. In the meta-analysis by Yamada et al [138] there were no differences between biosimilar insulins and the original insulins in relation to: HbA1c, fasting plasma glucose, hypoglycaemia, injection site reactions, insulin antibodies, allergic reactions and mortality.…”

Section: Insulinsmentioning

confidence: 98%

Therapy of Type 2 Diabetes

Landgraf

Aberle

Birkenfeld

et al. 2019

Exp Clin Endocrinol Diabetes

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The practical recommendations of the German Diabetes Society/ Deutsche Diabetes Gesellschaft (DDG) together with the German Society for Internal Medicine/Deutschen Gesellschaft für Innere Medizin (DGIM) are based on the contents of the National Treatment Guideline (Nationale Versorgungsleitlinie NVL) "Therapy of Type 2 Diabetes" [1]. The modifications in therapy and their justifications made in the present DDG practical recommendations were updated on the basis of new randomized controlled trials (RCTs) and meta-analyses and were consented by the DDG and the DGIM. Definition of Type 2 DiabetesType 2 diabetes is a chronic, very heterogeneous, multi-factorial, progressive disease characterized by inherited and acquired insulin resistance and qualitative and quantitative insulin secretion disturbances.Influenceable and uninfluenceable risk factors for type 2 diabetes are listed in the "Risk factors for type 2 diabetes" infobox. Therapeutic goalsIn the present recommendations, target ranges are identified which -with varying levels of strengths of evidence -inform the physician and the patient on which target range/target value should be aimed for according to current medical knowledge based on evidence and consensus. The main objective remains to set individual therapy goals primarily together with the patient and possibly his or her relatives and agreeing them optimally in writing on a quarterly basis (e. g. in the Health Passport Diabetes). General and specific therapeutic goalsThe therapeutic goals of people with type 2 diabetes depend on patient preference, comorbidity, duration of the disease, age and life expectancy, quality of life, cultural conditions, psychosocial circumstances and possibilities as well as abilities of the persons S73This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

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“…However, the study data suggest similar clinical efficacy and safety of these BioIns. In a second systematic review and meta-analysis by a Japanese group of researchers, 10 trials were assessed (two trials each on four BioIns, and one trial each on two others) (17). This metaanalysis found no differences between long-acting BioIns and originator insulins with regard to reduction in glucose control (i.e., improvement in HbA1c) or reduction in fasting plasma glucose, mortality, injection site reactions, insulin antibodies, or allergic reactions.…”

Section: Reviews Systematic Reviews and Meta-analysismentioning

confidence: 99%

New Insulins, Biosimilars, and Insulin Therapy

Danne

Heinemann

Bolinder

2019

Diabetes Technology & Therapeutics

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adjunct therapy with sodium-glucose cotransporter 2 inhibitors in patients with type 1 diabetes have become available and regulatory submissions are on the way, with decisions expected early next year. These drugs have the potential of addressing common side effects of insulin therapy such as glycemic variability, weight gain, or hypoglycemia. This must be balanced against notable untoward effects such as increased risk for genital mycotic infections or diabetic ketoacidosis. Mealtime insulin should ideally be absorbed very quickly after injection to counteract the rise in blood glucose with food consumption. Regarding the next-generation mealtime insulin Fiasp (NovoNordisk), it is now available in several markets and more data from the clinical Onset trial program with FiAsp were published or presented during the last year. As we outlined in the previous yearbook, these insulins where thought to be of particular value in insulin pump therapy. However, when the results of the Onset 5 FiAsp pump trial were presented during the 2017 ATTD meeting, the results were controversial. While we are still waiting for the eventual publication of this study, Eli Lilly initiated the PRONTO-Pump phase 3 trial to evaluate the compatibility and safety of their ultrarapid formulation LY 900014 or trepostinil lispro compared with insulin lispro in February 2018. Although clinical data of Adocia's ultra-rapid insulin-known as BioChaperone Lispro-was originally developed together with Lilly, this collaboration was terminated as we reported in last year's article. While initial data for treatment in people with type 1 and type 2 diabetes (T1D and T2D) have now been published, Adocia is still left without a partner to help get BioChaperone Lispro through critical phase 3 trials. Adocia won its first claim against Eli Lilly & Company regarding a disputed milestone payment, and additional claims will be assessed in another hearing, but a decision is not expected until 2019 and the future of the program remains unclear at this time. While the two ultra-long-acting basal insulin analogs, Toujeo (Sanofi) and Tresiba (Novo Nordisk) have now been on the market for several years, we are entering a time during which the efficacy in reducing the risk for hypoglycemia with the ultra-longacting insulins is studied in direct head-to-head randomized controlled trials and also with different methodologies including continuous glucose monitoring. As our review concludes, uncertainty still remains whether there are any clinically meaningful differences between the two at the present time. The first biosimilar insulin (BioIns)-an insulin glargine developed by Eli Lilly and Boehringer Ingelheim called Abasaglar in the EU and Basaglar in the United States (which was approved in the United States, but not as BioIns) has been on the market now for 1 to 2 years in the EU and the United States. It appears as if this BioIns has gained more market acceptance in the United States than in the EU; it is preferred over the originator insulin glargine in major U.S. ...

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Biosimilar vs originator insulins: Systematic review and meta‐analysis

Cited by 27 publications

References 18 publications

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

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

Therapy of Type 2 Diabetes

New Insulins, Biosimilars, and Insulin Therapy

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