门冬胰岛素生物类似药(Sanofi)(Insulin aspart biosimilar(Sanofi)) - 药物靶点：INSR_在研适应症：2型糖尿病，糖尿病_专利_临床

概要

基本信息

药物类型

生物类似药、多肽激素

别名

Insulin aspart Biosimilar (Sanofi)、SAR-Asp、门冬胰岛素生物类似药（Sanofi）

+ [5]

靶点

INSR

作用方式

激动剂

作用机制

INSR激动剂(胰岛素受体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Sanofi Winthrop Industrie SASanofi-Aventis Australia Pty Ltd.Sanofi KK

+ [2]

非在研机构

Sanofi

权益机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2020-06-25),

糖尿病

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 4857

当前序列信息引自: *****

Sequence Code 31953

当前序列信息引自: *****

关联

9

项与门冬胰岛素生物类似药(Sanofi) 相关的临床试验

NCT03874715

/ Completed临床3期

Randomized, Open Label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog® Versus Continuous Use of NovoLog in Participants With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Primary Objective:
To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin glargine.
Secondary Objectives:
* To compare the effects of alternating administration of SAR341402 and NovoLog with continuous use of NovoLog on immunogenicity.
* To evaluate the safety of alternating administration of SAR341402 and NovoLog versus continuous use of NovoLog.
* To compare other PK parameters between the two treatment arms (alternating administration of SAR341402 and NovoLog and continuous use of NovoLog).

开始日期2019-03-11

申办/合作机构

Sanofi

NCT03436498

/ Completed临床1期

Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)

Primary Objective:
- To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms of the number of patients with infusion set occlusions.
Secondary Objectives:
* To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of unexplained hyperglycemia.
* To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of:
* Intervals for infusion set changes.
* Number of patients with insulin pump for "non-delivery" alarm.
* Patient observation of infusion set occlusion.
* Adverse events and serious adverse events.
* Number of patients with hypoglycemic events [according to ADA (American Diabetes Association) Workgroup on hypoglycemia].

开始日期2018-05-10

申办/合作机构

Sanofi

NCT03916601

/ Completed临床1期

A Randomized, Double-blind, Single-dose, Cross-over Study in Two Cohorts to Compare Exposure and Activity of SAR341402 Mix 70/30 to Novolog® Mix 70/30, Novomix® 30 and SAR341402 Rapid-Acting Solution Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

Primary Objectives:
* To demonstrate similarity in exposure of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and NovoMix 30 (cohort 1).
* To demonstrate distinctiveness in early and intermediate exposure of SAR341402 Mix 70/30 compared to SAR341402 rapid-acting solution (cohort 2).
Secondary Objectives:
* To demonstrate similarity in activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and NovoMix 30.
* To demonstrate distinctiveness in early and intermediate activity of SAR341402 Mix 70/30 compared to SAR341402 rapid-acting solution.
* To assess the safety and tolerability of SAR341402 rapid-acting solution and SAR341402 Mix 70/30.

开始日期2017-12-13

申办/合作机构

Sanofi

100 项与门冬胰岛素生物类似药(Sanofi) 相关的临床结果

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100 项与门冬胰岛素生物类似药(Sanofi) 相关的转化医学

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100 项与门冬胰岛素生物类似药(Sanofi) 相关的专利（医药）

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14

项与门冬胰岛素生物类似药(Sanofi) 相关的文献（医药）

2025-07-01·Journal of diabetes science and technology

Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial

Article

作者: Barnes, Cathy ; Nakhle, Samer ; Wernicke-Panten, Karin ; Al-Karadsheh, Amer ; Pierre, Suzanne ; Teichert, Lenore ; Mandry, Jose ; Rotthaeuser, Baerbel ; Mukherjee, Bhaswati ; Shah, Viral N. ; Bailey, Timothy S. ; Kramer, Daniel ; Schmider, Wolfgang

Background::

SAR341402 insulin aspart (SAR-Asp) is a rapid-acting insulin analog developed as an interchangeable biosimilar to the marketed insulin aspart reference product (NovoLog; NN-Asp). GEMELLI X was a randomized controlled trial to assess outcomes with a biosimilar in line with the US Food and Drug Administration requirements for designation as an interchangeable biosimilar. This report assessed whether multiple switches between SAR-Asp and NN-Asp lead to equivalent safety and efficacy compared with continuous use of NN-Asp in adults with type 1 diabetes (T1D) treated with multiple daily injections, using once-daily insulin glargine U100 (Lantus) as the basal insulin.

Methods::

This open-label randomized (1:1), parallel-group, phase 3 trial compared four × four weeks of alternating use of individually titrated SAR-Asp and NN-Asp (NN-Asp for first four weeks, SAR-Asp in last four weeks; switching group) vs 16 weeks of continuous use of NN-Asp (nonswitching group). End points included pharmacokinetics, immunogenicity, adverse events, hypoglycemia, insulin dose, and change in efficacy parameters.

Results::

Of the 210 patients randomized, 200 (95.5%) completed the trial. Patients assigned to switching group (n = 104) and nonswitching group (n = 106) showed similar safety and tolerability, including anti-insulin aspart antibody responses, adverse events, and hypoglycemia. At week 16, there was no relevant difference between switching vs nonswitching groups in the change from baseline in glycated hemoglobin (least square [LS] mean difference = 0.05% [95% confidence interval [CI] = −0.13, 0.22]; 0.50 mmol/mol [−1.40, 2.39]), fasting plasma glucose (LS mean difference = 0.23 mmol/L [95% CI = −1.08, 1.53]; 4.12 mg/dL [−19.38, 27.62]), and changes in insulin dosages.

Conclusions::

Alternating doses of SAR-Asp and NN-Asp compared with continuous use of NN-Asp showed similar safety, immunogenicity, and clinical efficacy in adults with T1D. This study supports interchangeability between SAR-Asp and NN-Asp in T1D management.

2025-06-23·MEDICAL LETTER ON DRUGS AND THERAPEUTICS

In brief: Merilog - a NovoLog biosimilar.

Article

2024-02-01·Diabetes, obesity & metabolism

Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial

Article

作者: Jose Mandry MD ; Wolfgang Schmider PhD ; Daniel Kramer PhD ; Samer Nakhle MD ; Viral N. Shah MD ; Baerbel Rotthaeuser PhD ; Karin Wernicke-Panten MD ; Timothy S. Bailey MD ; Lenore Teichert MSc ; Bhaswati Mukherjee MD ; Cathy Barnes MD ; Amer Al-Karadsheh MD ; Suzanne Pierre MSc

Abstract:

Aim:

To assess whether multiple switches between SAR341402 biosimilar insulin aspart (SAR‐Asp) and the insulin aspart reference product (NovoLog; NN‐Asp) leads to equivalent pharmacokinetic (PK) exposure compared with continuous use of NN‐Asp in adults with type 1 diabetes (T1D).

Materials and Methods:

This multicentre, open‐label, phase 3 study randomized (1:1) 210 subjects with T1D treated with once‐daily insulin glargine U100 as basal insulin to four 4‐week periods of alternating multiple daily injections of SAR‐Asp and NN‐Asp (NN‐Asp for the first 4 weeks, SAR‐Asp in the last 4 weeks; switching group) versus 16 weeks of continuous NN‐Asp (non‐switching group). At week 16, a single dose (0.15 U/kg) of SAR‐Asp in the switching group ( n = 95) or NN‐Asp in the non‐switching group ( n = 105) was given in the morning before breakfast. Primary PK endpoints were area under the plasma concentration curve (AUC) and maximum plasma concentration (C max ) of SAR‐Asp versus NN‐Asp after the single dose at week 16.

Results:

The extent of PK exposure was similar between the two treatments (SAR‐Asp in the switching group and NN‐Asp in the non‐switching group) at week 16, with point estimates of treatment ratios close to 1. The 90% confidence intervals for AUC treatment ratios were contained within 0.8‐1.25. For C max in the primary analysis set, the upper confidence limit was 1.32. This was because of the profiles of three participants with implausible high values. A prespecified sensitivity analysis excluding implausible values showed results contained within 0.8‐1.25.

Conclusions:

PK exposure of SAR‐Asp (switching group) and reference NN‐Asp (non‐switching group) were similar, supporting interchangeability between these two insulin aspart products.

17

项与门冬胰岛素生物类似药(Sanofi) 相关的新闻（医药）

2025-09-26

·FiercePharma

Sanofi expands $35-per-month pricing to all insulin products

After cutting the price of its most popular insulin Lantus to $35 per month, Sanofi now will do the same for its other insulin products. In an expansion of its previous moves to cut insulin prices, Sanofi will cap the price of each of its insulin products at $35 per month in the U.S. regardless of a patient's insurance status.The move, which goes into effect at the start of next year, comes two years after the company slashed the price of its most popular insulin, Lantus, to $35 monthly for those with commercial insurance.Before that, in June of 2022, Sanofi reduced the price of an unbranded Lantus biologic from $99 per month to $35 for those in the U.S. without insurance.Sanofi’s cost-cutting efforts have mirrored those of the world’s other two primary sellers of insulin—Novo Nordisk and Eli Lilly—and come as advanced insulin products and insulin biosimilars are reaching the market. In early 2023, each of the drugmakers cut their insulin prices in similar fashion, answering calls from then-President Joe Biden and Sen. Bernie Sanders, I-Vt., to charge prices for insulin in the U.S. that were more in line with what the drugmakers charged in other countries.Through the Inflation Reduction Act (IRA), Biden had already secured a reduction in the price of insulin for seniors on Medicare to $35.In 2021, the Rand Corporation pointed out that the average list price for insulin in Canada was $12, compared to $98.7 in the U.S. Due to its high price, many people in the U.S. that need the life-saving treatment had turned to rationing. Also pressuring the price of insulin downward were the introduction in of biosimilars—Biocon and Viatris’ Semglee in 2021 and Lilly’s interchangeable Rezvoglar in 2022, both of which were knockoffs of Lantus.Earlier this year, Sanofi won FDA approval for Merilog, the first biosimilar referencing Novo Nordisk’s rapid-acting insulin NovoLog, which is delivered by a subcutaneous shot five to 10 minutes before mealtime to help patients control glucose and limit blood sugar spikes.

上市批准

2025-07-16

·ETPharma

FDA approves Biocon Biologics rapid-acting Insulin Kirsty

Bengaluru: Biocon's biosimilars arm Biocon Biologics announced that the US Food and Drug Administration (FDA) has approved its rapid-acting Insulin Kirsty . The drug is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. As per the drugmaker the approved insulin is an interchangeable biosimilar to Novo Nordisk ’s NovoLog, which reported total sales of around $1.9 billion in 2024 in the US. Kirsty will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use, the company added. Notably, the drug has been on the market in Europe and Canada since 2022. “The FDA approval of Kirsty, is a significant step forward in our efforts to make insulin more accessible, affordable and reinforces our commitment to scientific excellence and patient-centric innovation,” said Shreehas Tambe, CEO & MD, Biocon Biologics said. Besides Biocon, in February this year, FDA had also approved Sanofi’s Merilog as a biosimilar to Novo Nordisk’s NovoLog. By Online Bureau ,

上市批准

2025-07-15

·Firstwordpharma

Biocon gets stock bump after FDA approves interchangeable insulin biosimilar

Shares in Biocon ticked up about 3% on Tuesday after the FDA greenlit its biosimilar version of Novo Nordisk's rapid-acting human insulin analogue — the first to be deemed interchangeable with NovoLog (insulin aspart).The biosimilar's US approval is years behind other regions; Kirsty (insulin aspart-xjhz) has been available in the EU and Canada since 2022. Biocon gained Kirsty via its $3.3-billion takeout of Viatris in 2022, along with another insulin biosimilar, Semglee (insulin glargine-yfgn), which is interchangeable with Sanofi's Lantus (insulin glargine).While Biocon's product is the first to hold interchangeable status, it's the second insulin aspart biosimilar approved by the US regulator. In February, the FDA cleared Sanofi's Merilog (insulin aspart-szjj).NovoLog was part of the initial batch of 10 drugs subject to pricing negotiations under the US Inflation Reduction Act (IRA). The diabetes treatment reportedly cost the US government $2.6 billion in Part D prescriptions in 2023, but starting in 2026 its list price will be slashed by 76%.

上市批准生物类似药专利到期

100 项与门冬胰岛素生物类似药(Sanofi) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10AD05 A10AB05	DB01306

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	日本	Sanofi KK	2021-03-23
糖尿病	欧盟	Sanofi Winthrop Industrie SA	2020-06-25
糖尿病	冰岛	Sanofi Winthrop Industrie SA	2020-06-25
糖尿病	列支敦士登	Sanofi Winthrop Industrie SA	2020-06-25
糖尿病	挪威	Sanofi Winthrop Industrie SA	2020-06-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床3期	美国	Sanofi	2017-08-02
1型糖尿病	临床3期	日本	Sanofi	2017-08-02
1型糖尿病	临床3期	芬兰	Sanofi	2017-08-02
1型糖尿病	临床3期	德国	Sanofi	2017-08-02
1型糖尿病	临床3期	匈牙利	Sanofi	2017-08-02
1型糖尿病	临床3期	波兰	Sanofi	2017-08-02
1型糖尿病	临床3期	俄罗斯	Sanofi	2017-08-02

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03874715 (GEMELLI X, Pubmed \| J Diabetes Sci Technol)	临床3期	1型糖尿病	210	SAR341402 Insulin Aspart	廠積繭鏇糧醖膚顧構鬱(壓積艱艱壓淵齋餘衊遞): LS mean difference = 0.23 更多	积极	2025-07-01
				Originator Insulin Aspart
FDA_CDER 人工标引	N/A	1型糖尿病	283	Insulin aspart + NPH (Pediatric)	衊艱網鑰選襯鏇鹹窪構(簾繭鬱顧選範膚獵糧積) = 遞觸壓夢遞繭簾醖選蓋築簾艱網鹹憲廠壓鏇襯 (衊憲壓鹹憲襯構壓鬱廠, 1.0)	积极	2025-02-14
				Regular Human Insulin + NPH (Pediatric)	衊艱網鑰選襯鏇鹹窪構(簾繭鬱顧選範膚獵糧積) = 簾鑰鑰蓋醖糧顧齋獵觸築簾艱網鹹憲廠壓鏇襯 (衊憲壓鹹憲襯構壓鬱廠, 1.1)
FDA_CDER 人工标引	N/A	2型糖尿病	176	Insulin aspart + NPH	願膚夢觸廠壓製選顧壓(選憲壓簾製窪願齋顧網) = 醖製夢簾窪鏇齋顧齋夢範鑰餘壓簾顧網窪壓醖 (衊鹹艱襯衊壓網繭鹽鬱, 1.0)	积极	2025-02-14
				Regular Human Insulin + NPH	願膚夢觸廠壓製選顧壓(選憲壓簾製窪願齋顧網) = 鬱選簾艱範鹹餘範醖醖範鑰餘壓簾顧網窪壓醖 (衊鹹艱襯衊壓網繭鹽鬱, 0.8)
FDA_CDER 人工标引	N/A	1型糖尿病	-	Insulin aspart + NPH (Adults)	鏇繭簾簾鑰齋襯淵艱獵(構獵顧糧築齋鑰憲窪淵) = 淵鬱鏇觸鹹鏇獵糧夢遞鏇餘齋觸網齋簾膚鬱願 (顧餘衊範願淵蓋窪窪網, 0.8)	积极	2025-02-14
				Regular Human Insulin + NPH (Adults)	鏇繭簾簾鑰齋襯淵艱獵(構獵顧糧築齋鑰憲窪淵) = 積觸膚齋繭獵齋餘願壓鏇餘齋觸網齋簾膚鬱願 (顧餘衊範願淵蓋窪窪網, 0.8)
NCT03874715 (GEMELLI X, CTgov)	临床3期	1型糖尿病	210	Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	觸淵鑰選蓋選築鑰觸淵(觸遞窪鏇選襯壓糧構醖) = 淵鑰窪願窪顧構積鏇膚醖築願鬱膚鹹鏇顧願鹹 (遞艱製構範蓋襯鹽夢觸, 18300) 更多	-	2023-07-21
				Insulin glargine U100+Insulin Aspart (Non-switching: NovoLog)	觸淵鑰選蓋選築鑰觸淵(觸遞窪鏇選襯壓糧構醖) = 構製窪廠鹽鑰鬱憲繭襯醖築願鬱膚鹹鏇顧願鹹 (遞艱製構範蓋襯鹽夢觸, 6530) 更多
NCT03211858 (GEMELLI 1, Pubmed) 人工标引	临床3期	糖尿病	597	Insulin Glargine+SAR341402	選網積廠醖夢醖觸鑰築(鏇網糧壓築壓製願鬱選) = 壓憲壓蓋繭鏇獵構憲鹽蓋觸繭觸衊遞襯襯壓衊 (蓋鏇觸醖鹽獵鏇鬱鬱鏇 )	相似	2020-02-01
				Insulin Glargine+Originator Insulin Aspart	選網積廠醖夢醖觸鑰築(鏇網糧壓築壓製願鬱選) = 鏇襯顧衊淵顧願獵糧築蓋觸繭觸衊遞襯襯壓衊 (蓋鏇觸醖鹽獵鏇鬱鬱鏇 )
NCT03211858 (GEMELLI1 \| GEMELLI 1, CTgov)	临床3期	1型糖尿病	597	Insulin glargine (HOE901)+Insulin aspart (SAR341402)	齋齋構淵餘鬱憲積餘鏇(淵繭鏇襯膚願觸顧憲鑰) = 築醖窪遞夢衊襯製構遞構鬱窪鏇蓋蓋獵齋製選 (夢簾遞鑰艱淵壓網衊夢, 0.042) 更多	-	2019-08-08
				Insulin glargine (HOE901)+NovoLog (NovoLog/NovoRapid)	齋齋構淵餘鬱憲積餘鏇(淵繭鏇襯膚願觸顧憲鑰) = 顧鏇觸壓範憲鹹壓選遞構鬱窪鏇蓋蓋獵齋製選 (夢簾遞鑰艱淵壓網衊夢, 0.041) 更多
NCT00607087 (PUMP, CTgov)	临床4期	1型糖尿病	289	Insulin (Insulin Glulisine)	壓壓廠鬱廠遞鑰鏇觸簾 = 簾齋積鬱餘範糧廠鏇獵窪鹹鬱襯餘築窪範鏇鹽 (艱蓋膚獵獵餘窪糧獵蓋, 簾鑰構鏇餘獵夢憲衊簾 ~ 鹽鹽衊餘遞淵窪憲衊構) 更多	-	2010-07-30
				Insulin Aspart (Insulin Aspart)	壓壓廠鬱廠遞鑰鏇觸簾 = 襯繭鏇齋遞鑰蓋齋襯遞窪鹹鬱襯餘築窪範鏇鹽 (艱蓋膚獵獵餘窪糧獵蓋, 簾簾憲衊鏇憲壓廠繭壓 ~ 構鹽醖鏇鹹餘膚繭構範) 更多