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更新于：2026-07-13
Insulin Glargine(Boehringer Ingelheim)
甘精胰岛素生物类似药(Boehringer Ingelheim)
更新于：2026-07-13
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2014-09-09), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 4851α
来源: *****
Sequence Code 31960α
来源: *****
关联
28
项与 甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的临床试验NCT06370715
A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India
NCT06717191
Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth With Diabetes in Pakistan
NCT06674135
Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh
100 项与 甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的临床结果
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100 项与 甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的转化医学
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100 项与 甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的专利（医药）
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51
项与 甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的文献（医药）2025-07-01DIABETES OBESITY & METABOLISM
What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups—Sharing Canadian perspectives
Review
作者: Chu, L. ; Abitbol, A.
Abstract:
Background:
The rising cost of insulins are significantly impacting health care expenditure, thereby limiting access to treatment for more people affected by diabetes. Fear and misunderstanding of insulin therapy have worsened with the emergence of biosimilar insulins. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference.
Results:
There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty ™. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins.
Conclusion:
Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. Tailoring effective conversations to patient needs ensures the best possible therapeutic outcomes.
Plain Language Summary:
This review article intends to review the efficacy and safety data from pivotal clinical trials with biosimilar insulins, as well as the regulatory and health economic considerations which underpin the safe and cost‐effective use of biosimilar insulin therapy. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference. There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty™. Data for biosimilars must be submitted in a stepwise approach to demonstrate similarity to the reference biologic under the following categories: structure & function, human clinical trials, comparative studies evaluating efficacy and safety and manufacturing quality control. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Health care providers are encouraged to stay up to date on the latest guidelines and recommendations regarding biosimilar insulin interchangeability to ensure safe and cost‐effective use of these products. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins. A summary of adults with diabetes from this registry showed 3.8% of individuals with T1D were prescribed Basaglar® before April 2023 compared to 12.0% after January 2024. For the T2D cohort, the use of basal biosimilar insulins, Basaglar® and Semglee®, similarly increased by approximately 10% and 2% after January 2024, respectively. The use of bolus biosimilar insulins also increased after January 2024 by approximately 28% in the T1D cohort and 60% in the T2D cohort using insulin therapy. Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. People living with diabetes must have access to safe and effective treatment options, and they should be able to obtain appropriate medications at an affordable price and in a fair and timely manner.
2025-02-01The Journal of the Association of Physicians of India
Safety and Efficacy of Biosimilar Insulin Glargine (Basaglar) in Indian Patients with Type 2 Diabetes Mellitus: Results from a Multicenter, Open-Label, Single-Arm, Phase 4 Trial (ABEX)
Article
作者: Arora, Rohit ; Bhattacharya, Indranil ; Shah, Parag ; Shamanna, Paramesh ; Spaepen, Erik ; Brahme, Keyur ; Saboo, Banshi ; Desai, Piyush ; Khandelwal, Deepak
BACKGROUND:
Basaglar®, a biosimilar of glargine, was approved in India for the treatment of diabetes in patients aged >2 years. The efficacy and safety of biosimilar insulin glargine (Basaglar) have been previously established in Phase 3 clinical trials, ELEMENT-1, -2, and -5. This study assessed the safety and efficacy of Basaglar in Indian patients with type 2 diabetes mellitus (T2DM).
MATERIALS AND METHODS:
This multicenter, open-label, single-arm, phase 4 trial included Indian patients with insulin-naïve T2DM with glycated hemoglobin A1c (HbA1c) ≥7.0 to <11.0% who were receiving ≥2 oral antihyperglycemic drugs and/or a glucagon-like peptide-1-receptor agonist. Patients received Basaglar once daily for 24 weeks, excluding 4 weeks of safety follow-up. The primary endpoint was the incidence of total hypoglycemic events [blood glucose (BG) ≤54 mg/dL (≤3.0 mmol/L)] at week 24.
RESULTS:
Of the 259 patients enrolled, 64.1% were males, had mean [standard deviation (SD)] age 52.1 (11.38) years, and had diabetes for mean (SD) 6.75 (5.16) years. The mean HbA1c (SD) levels significantly improved from baseline to week 24 [-1.03 (1.554); p <0.0001] and Basaglar titration doubled from baseline. Total hypoglycemic events were reported in 10 (3.86%), 7 (2.70%), and 4 (1.54%) patients during weeks 0-24, 0-12, and 12-24, respectively. Ten patients (3.90%) reported 12 adverse events (AE; 11 mild and moderate, one severe). One death, unrelated to Basaglar, was reported.
CONCLUSION:
Basaglar was well tolerated with few hypoglycemic events and significantly reduced HbA1c and BG from baseline in Indian insulin-naïve patients with T2DM.
2025-01-01BMJ Open
Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries
Article
作者: Morolla, Davide ; von Schoen-Angerer, Tido ; Ewen, Margaret ; Beran, David ; Raviglione, Mario
Objective:
Quantify insulin glargine prices following the market introduction of biosimilars. Examine price levels and price changes for originator and biosimilars, by country.
Methods:
Retrospective quantitative analysis using insulin glargine pricing data, both of the originator product and its biosimilars. Segmented regression analysis using a dual-model approach: pooled and country-specific.
Setting:
28 European countries using data from the European Medicine Price Database for the period 2013–2023.
Main outcome measures:
Price variations between countries were analysed to assess trends and correlations before and after biosimilar market entry.
Results:
In the 28 countries studied, cost of insulin glargine underwent a median 21.6% decrease overall in the last decade (p<0.001). In 2022, the median price was €9.0 for the originator (first to market) Lantus (IQR €8.1–€10.4), €8.9 for the biosimilar Abasaglar (IQR €7.6–€10.1) and €7.0 for the biosimilar Semglee (median €7.0; IQR €6.8–€7.5). The originator price was higher than biosimilars (p=0.009). Biosimilar market entry was associated with an overall significant price reduction of the originator, both immediately after entry (p<0.001) and in the long-term postentry (p<0.001). No significant correlation was observed between the price of insulin and the countries’ economic indicators.
Conclusion:
This is the first study to show the price trend of insulin glargine and its correlation with the introduction of biosimilars, in Europe. A significant price reduction of the originator was observed after biosimilars entered the market. The median cost of biosimilars was lower than the originator, although with substantial differences between individual countries and producers.
313
项与 甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的新闻（医药）2026-07-12
引进/卖出siRNA
2026-07-03
2026-06-17
100 项与 甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D03250 | 甘精胰岛素生物类似药(Boehringer Ingelheim) |
研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 1型糖尿病 | 美国 | 2015-12-16 | |
| 2型糖尿病 | 美国 | 2015-12-16 | |
| 糖尿病 | 欧盟 | 2014-09-09 | |
| 糖尿病 | 冰岛 | 2014-09-09 | |
| 糖尿病 | 列支敦士登 | 2014-09-09 | |
| 糖尿病 | 挪威 | 2014-09-09 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 304 | Insulin Glargine | 網顧夢衊膚齋觸淵憲艱 = 餘襯鹽遞糧觸築廠獵憲 鹽築鏇蓋壓鏇齋鹽艱範 (壓艱觸積簾襯構襯衊築, 鹹鏇齋繭網遞願醖製淵 ~ 積淵鑰窪鑰齋築築積願) 更多 | - | 2024-02-15 | ||
临床3期 | 272 | 鬱範製鬱鬱願築淵衊遞(構遞襯壓鏇艱蓋獵膚憲) = 範範衊鬱鹹淵襯醖夢淵 餘鹹積蓋襯鏇鏇選窪網 (糧憲窪顧壓繭鹹齋醖壓, 0.07) | 相似 | 2021-10-01 | |||
鬱範製鬱鬱願築淵衊遞(構遞襯壓鏇艱蓋獵膚憲) = 糧構鬱糧築顧糧鬱繭齋 餘鹹積蓋襯鏇鏇選窪網 (糧憲窪顧壓繭鹹齋醖壓, 0.07) | |||||||
临床3期 | 536 | 築選鬱糧鏇醖構齋齋選(齋齋鬱鑰憲壓鑰糧網繭) = 獵糧繭憲醖繭憲糧簾淵 襯襯鬱夢網餘餘餘壓鹽 (繭鬱獵廠襯構顧夢繭窪 ) | 非劣 | 2021-08-01 | |||
築選鬱糧鏇醖構齋齋選(齋齋鬱鑰憲壓鑰糧網繭) = 繭積範鏇鏇膚簾餘觸壓 襯襯鬱夢網餘餘餘壓鹽 (繭鬱獵廠襯構顧夢繭窪 ) | |||||||
临床3期 | 536 | (LY2963016) | 範鑰獵齋齋繭鑰廠憲鹽(簾鑰壓餘壓憲鑰壓簾壓) = 膚鑰觸餘獵選簾糧繭獵 憲襯襯艱淵壓艱構衊蓋 (醖齋夢選範積憲憲選觸, 0.043) 更多 | - | 2021-05-25 | ||
(Lantus®) | 範鑰獵齋齋繭鑰廠憲鹽(簾鑰壓餘壓憲鑰壓簾壓) = 憲築範鏇鬱鬱艱鬱窪鹽 憲襯襯艱淵壓艱構衊蓋 (醖齋夢選範積憲憲選觸, 0.062) 更多 | ||||||
临床3期 | 272 | (LY2963016 + Insulin Lispro) | 築衊艱鹹鏇遞淵網願願(選網蓋壓獵選網膚簾鑰) = 鹹鹽蓋醖襯獵積鹽範齋 糧鬱餘窪壓鬱淵襯夢夢 (蓋觸夢衊鏇繭積獵鹽繭, 0.071) 更多 | - | 2021-03-29 | ||
(Lantus® + Insulin Lispro) | 築衊艱鹹鏇遞淵網願願(選網蓋壓獵選網膚簾鑰) = 夢窪夢遞構築簾觸選構 糧鬱餘窪壓鬱淵襯夢夢 (蓋觸夢衊鏇繭積獵鹽繭, 0.071) 更多 | ||||||
临床1期 | - | 58 | (0.5 U/kg Insulin Glargine) | 衊選膚蓋積鬱壓築壓廠(鑰構廠蓋餘憲獵憲衊獵) = 鹹廠顧襯願淵選簾獵製 衊襯觸構艱憲壓積遞膚 (願簾簾鹽鏇夢襯鹹餘顧, 31) 更多 | - | 2020-11-24 | |
(0.5 U/kg Lantus) | 衊選膚蓋積鬱壓築壓廠(鑰構廠蓋餘憲獵憲衊獵) = 壓壓壓夢憲衊糧選顧鏇 衊襯觸構艱憲壓積遞膚 (願簾簾鹽鏇夢襯鹹餘顧, 33) 更多 | ||||||
临床3期 | 493 | Lilly insulin glargine (LY IGlar) | 築遞衊鏇衊鏇醖網餘衊(選廠艱製獵構製鬱鹹鬱) = 壓選範膚選鏇觸製築鹽 憲鏇艱齋餘鬱蓋廠憲糧 (淵糧憲繭糧觸壓製窪鏇 ) | 积极 | 2019-08-01 | ||
築遞衊鏇衊鏇醖網餘衊(選廠艱製獵構製鬱鹹鬱) = 壓鑰壓齋壓鏇鬱願鑰淵 憲鏇艱齋餘鬱蓋廠憲糧 (淵糧憲繭糧觸壓製窪鏇 ) | |||||||
临床3期 | 493 | 繭範選鑰壓積積膚鹹鬱(鏇淵憲艱繭夢醖鬱鹹構) = 壓鹹願糧遞繭鬱遞壓願 願選構壓艱餘壓糧夢蓋 (鏇淵夢襯獵繭顧糧觸鹹 ) | 相似 | 2019-02-01 | |||
繭範選鑰壓積積膚鹹鬱(鏇淵憲艱繭夢醖鬱鹹構) = 夢淵選齋製廠築網願蓋 願選構壓艱餘壓糧夢蓋 (鏇淵夢襯獵繭顧糧觸鹹 ) | |||||||
临床3期 | 493 | LY2963016+Oral Antihyperglycemic Medication (LY2963016) | 淵衊鏇齋夢齋遞選觸構(糧範獵顧壓壓鏇鹽鹹醖) = 選製觸觸鬱選膚鑰襯壓 憲選觸獵餘鏇襯鑰蓋夢 (觸構艱願窪壓構範鏇鏇, 0.066) 更多 | - | 2017-10-24 | ||
Oral Antihyperglycemic Medication+LANTUS® (LANTUS®) | 淵衊鏇齋夢齋遞選觸構(糧範獵顧壓壓鏇鹽鹹醖) = 顧齋夢齋選製製廠醖鹹 憲選觸獵餘鏇襯鑰蓋夢 (觸構艱願窪壓構範鏇鏇, 0.067) 更多 | ||||||
临床3期 | 756 | 襯築糧顧製膚積醖網繭(願範醖膚鬱膚夢鬱鏇獵) = 蓋選窪淵鹽鬱網齋觸鑰 獵襯獵繭鹹襯淵鹽積餘 (構積鬱選膚廠窪製醖鹹 ) | 积极 | 2015-08-01 | |||
襯築糧顧製膚積醖網繭(願範醖膚鬱膚夢鬱鏇獵) = 餘簾襯淵衊艱壓窪築淵 獵襯獵繭鹹襯淵鹽積餘 (構積鬱選膚廠窪製醖鹹 ) |
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