Delving into the Latest Updates on Insulin glargine (Sanofi) with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

Insulin Glargine (Genetical Recombination), INSULIN GLARGINE RECOMBINANT, GLA-100

+ [14]

Target

INSR

Action

agonists

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Inactive Indication

Acute myocardial infarctionDiabetes Mellitus, Noninsulin-Dependent, 2Diabetic Coma+ [5]

Originator Organization

Sanofi

Active Organization

Sanofi

Sanofi-Aventis U.S. LLCSanofi-Aventis Australia Pty Ltd.

+ [2]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (20 Apr 2000),

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 4851

Source: *****

Sequence Code 31960

Source: *****

Participants (N = 6246) from SURPASS 1–5 were randomized to once weekly tirzepatide (5, 10 or 15 mg) or comparator (once weekly placebo, once weekly semaglutide 1 mg, insulin degludec or insulin glargine). Continuous time spent with HbA1c < 7.0% (53 mmol/mol), ≤6.5% (48 mmol/mol) and ≥5% body weight reduction and combined HbA1c ≤ 6.5% (48 mmol/mol) with a ≥5% body weight reduction were assessed through 40 weeks (SURPASS‐1, ‐2, and ‐5) or 52 weeks (SURPASS‐3 and ‐4). The non‐parametric Wilcoxon rank sum test was used to compare the median duration of continuous time spent in control, and logistic regression was used to analyse the proportion of participants achieving glycaemic control and body weight reduction at any time points or at the end of the primary study period.

Results:

Median time spent with HbA1c < 7.0% (53 mmol/mol) was 80% (tirzepatide) versus 70% (semaglutide) and 0% (placebo) of the treatment duration in 40‐week studies, and 77%–85% (tirzepatide) versus 62% (insulin degludec) and 23% (insulin glargine) of the treatment duration in 52‐week studies (p < 0.001). Time spent with HbA1c < 7.0% (53 mmol/mol) was generally similar across all tirzepatide doses in each study. Dose‐dependent increases in time spent with ≥5% body weight reduction were observed with tirzepatide (median time spent: 20%–77% with tirzepatide versus 25% with semaglutide 1 mg) (p < 0.001). Tirzepatide‐treated participants experienced longer time spent with HbA1c ≤ 6.5% (48 mmol/mol) and ≥5% body weight reduction versus semaglutide (median: 35%–60% vs. 7%) (p < 0.001).

Conclusions:

In this post hoc analysis, people with T2D experienced substantially longer continuous time in glycaemic control and more sustained body weight reductions with tirzepatide versus placebo and active comparators.

01 Jun 2025·DIABETES OBESITY & METABOLISM

Efficacy and safety of iGlarLixi versus IDegAsp in people with type 2 diabetes inadequately controlled with basal insulin: A systematic literature review and network meta‐analysis of non‐Asian studies

Review

Author: Hafidh, Khadija ; Mehta, Roopa ; Faraoun, Khadra ; Li, Xuan‐Tony ; Anaforoğlu, İnan ; Home, Philip ; Lauand, Felipe ; Djaballah, Khier ; Serafini, Paul ; Pourrahmat, Mir‐Masoud

Abstract:

Aims:

To estimate the relative treatment effect of iGlarLixi (a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide) versus premixed insulin IDegAsp (insulin degludec plus insulin aspart) in people with type 2 diabetes (T2D) who advanced from basal insulin to iGlarLixi or IDegAsp in non‐Asian studies.

Materials and Methods:

Randomized controlled trials (RCTs) were identified in a systematic review by searching Embase (including congress abstracts from 2021 to 2023), MEDLINE® and CENTRAL on 10 October 2023. Treatment outcomes from non‐Asian RCTs for people with T2D previously treated with basal insulin, who switched to iGlarLixi or IDegAsp, were compared using a network meta‐analysis (NMA). Data analysis was performed using R, version 4.0.2.

Results:

The NMA included four RCTs (N = 2535). The results of the NMA showed that iGlarLixi (n = 810) was associated with a significantly greater reduction in HbA1c versus IDegAsp (n = 454) (mean difference [MD]: −0.39 [95% credible interval, CrI: −0.58, −0.21] %‐units). iGlarLixi was also associated with a significantly greater likelihood of achieving an HbA1c of <7.0% (risk ratio: 1.42, 95% CrI: 1.18, 1.71). A greater reduction in postprandial glucose was observed with iGlarLixi versus IDegAsp (MD: −1.38 [95% CrI: −2.15, −0.63] mmol/L). A body weight benefit that favoured iGlarLixi versus IDegAsp was documented (MD: −1.54 [95% CrI: −2.26, −0.84] kg). Hypoglycaemia evaluation was inconclusive due to definitional differences between trials.

Conclusions:

Once‐daily iGlarLixi was associated with superior blood glucose control and body weight benefit compared with IDegAsp in insulin‐experienced populations with T2D in non‐Asian RCTs.

01 Jun 2025·DIABETES OBESITY & METABOLISM

An open‐label, multiple ascending dose trial of orally administered insulin Tregopil in patients with type 1 diabetes mellitus to evaluate its pharmacokinetics, pharmacodynamics, safety and tolerability

Article

Author: Plum‐Moerschel, Leona ; Samsonraj, R. ; Loganathan, Subramanian ; Panda, Jayanti ; Murugesan, Sundara Moorthi Nainar ; Lou, Olivia ; Latres, Esther ; Gopu, C. L. ; Athalye, Sandeep Nilkanth ; Marwah, Ashwani

Abstract:

Aim:

This trial evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of oral insulin Tregopil (Part 1; results discussed in this paper) and the post‐prandial glucose control with different meal types in comparison with insulin aspart (Part 2) in patients with type 1 diabetes mellitus (T1DM).

Materials and Methods:

This Phase 1, open‐label, multiple ascending dose (30/45/60 mg/60 + 30 mg rescue insulin Tregopil) trial enrolled 37 patients with T1DM (3 female [8.1%], 34 male [91.9%]; median age: 39.5 years). Following screening, patients entered a run‐in phase to optimize their basal‐bolus (insulin glargine and insulin aspart) insulin therapy, and insulin Tregopil was administered orally 10 min before the three major meals of the day in all cohorts during this period. Safety assessments included adverse events and hypo−/hyperglycaemic episodes, vital signs, electrocardiograms, laboratory safety parameters and physical examination. PK and PD were the secondary objectives.

Results:

The overall safety profile of insulin Tregopil indicated no safety concerns except a PD effect (hypoglycaemia). The incidence of hypoglycaemia did not increase with increasing doses of insulin Tregopil, and none of the episodes were severe. In general, the variability of the PK/PD parameters was high. Insulin Tregopil demonstrated a rapid onset of action, with peak blood concentrations reached within 15–20 min post‐dosing. Subsequently, insulin Tregopil exerted a PD effect for up to 105 min.

Conclusion:

Fixed‐dose insulin Tregopil reduced the requirement for insulin aspart supplementation, although it was not a viable stand‐alone option for the daily management of T1DM. Insulin Tregopil could be explored with a flexible dosing approach and be titrated based on individual needs.

Trial Registration:

The trial is registered at Clinicaltrials.gov (CT.gov identifier: NCT04141423). The ethical approval number for the protocol is 2019146.

149

News (Medical) associated with Insulin glargine (Sanofi)

24 Apr 2025

·endpts.com

Only two-thirds of FDA-approved biosimilars have launched, report finds

As President Donald Trump has sought to speed the development and approval of new biosimilar competition to expensive biologics, only 66% of FDA-approved biosimilars have actually been commercialized, more than a decade since the agency began approving them, a new Samsung Bioepis quarterly report found. The launch tally includes 10 new FDA biosimilar approvals in the first quarter of 2025 and five new launches, for 48 commercializations out of 73 approvals. Even still, blockbusters like AbbVie’s Humira and Amgen’s Enbrel have continued to thwart any major competition, as biosimilars to their cash cows first won FDA approval starting in 2016. In the case of Humira, the Samsung report explains how there are now 10 biosimilars priced at greater than 80% off the brand name, and seven at 85-87% off. And yet AbbVie still controls 77% of the overall adalimumab market. Similarly, four insulin glargine biosimilars have launched over the last five years to compete with Sanofi’s Lantus, first approved by FDA in 2000. That biosimilar competition has only captured 6% of the total market. On the flip side, biosimilar cancer treatments priced closer to their brand name counterparts are clearly capturing volume. Avastin, Herceptin and Rituxan biosimilars control more than three-quarters of their brand-name biologics’ markets. As far as reforms, the report notes that it typically costs between $100 million and $300 million and 7-8 years to develop a new biosimilar, but analyses from BCG suggest streamlining proposals could reduce development costs by $50 million to $225 million and timelines by 1-2 years.

Drug ApprovalBiosimilar

10 Apr 2025

·pipelinereview.com

Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio

BRIDGEWATER, NJ, USA and BENGALURU, Karnataka, India I April 10, 2025 I Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: “The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.” In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.** Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many “firsts” in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas. About JOBEVNE: The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab). The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of: * Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer. JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company. OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. **Sales projections are based on Biocon Biologics’ analysis of IQVIA 2023 data. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL) , a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It’s pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website www.bioconbiologics.com ; Follow us on X (formerly Twitter ): @BioconBiologics and LinkedIn : Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com ; Follow-us on X (formerly Twitter ) @bioconlimited and LinkedIn : Biocon for company updates. SOURCE: Biocon Biologics

Drug ApprovalImmunotherapy

21 Feb 2025

·endpts.com

Teva launches Stelara biosimilar at 85% discount as wider field emerges

Teva and its partner Alvotech on Friday followed Amgen in launching a biosimilar to Johnson & Johnson’s blockbuster immunosuppressive biologic Stelara, offering a steep discount. The Stelara biosimilar field is shaping up to be a crowded space, even though the government included Stelara in its first round of price negotiations and uptake for other biosimilars in crowded markets has slowed, like with AbbVie’s megablockbuster Humira, where there has been little brand name erosion . As with biosimilars to Humira, the biosimilars to Stelara are already offering a wide range of list prices, with Amgen’s launch at two prices — 5% off the brand name and another at about 80% off, according to Andrew Bourgoin, founder at All Things Biosimilar . Amgen is selling its biosimilars through Optum’s Nuvaila unit, and it isn’t the first to offer two different discounts to a brand-name biologic. The precedent was first set with Viatris’ interchangeable biosimilar for Sanofi’s insulin Lantus, known as Semglee, and continued with Humira, as PBMs often favor high list prices and high rebate products. Teva launched its Stelara biosimilar on Friday at an 85% discount, a spokesperson confirmed to Endpoints News . Two other Stelara biosimilars are also expected to launch by Monday, including Celltrion’s Steqeyma and Biocon’s Yesintek at between 86% and 90% off, Bourgoin said. Fresenius Kabi and Formycon also won approval for their Stelara biosimilar last September , while Accord Biopharma won approval for one last October. In 2024, J&J pulled in a little more than $10 billion from Stelara. While J&J had to go through the first round of drug price negotiations, and the back-and-forth with the government ultimately set a 66% discount off the list price, the biologic may ultimately be de-selected from the Inflation Reduction Act program, depending on how CMS interprets what’s known as “bona fide marketing” in the law. Anna Kaltenboeck, head of prescription drug reimbursement practice at consulting firm ATI Advisory, previously told Endpoints that the determination could depend on “whether or not the biosimilar is taking up market share.”

Drug ApprovalBiosimilar

100 Deals associated with Insulin glargine (Sanofi)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D03250	Insulin glargine (Sanofi)	A10AE04	DB00047

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus	European Union	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Iceland	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Liechtenstein	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Norway	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus, Type 1	United States	Sanofi-Aventis U.S. LLC	20 Apr 2000
Diabetes Mellitus, Type 2	United States	Sanofi-Aventis U.S. LLC	20 Apr 2000

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	United States	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Argentina	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Brazil	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Canada	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Mexico	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	United States	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Argentina	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Brazil	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Canada	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Mexico	Sanofi	01 Apr 2008

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Diabetes Mellitus, Type 2	568	甘精胰岛素U300 (初治)	qadgxxdopr(ybyuwtxpju) = iygvhbodoa lbimwiqcis (pfmoohdipj ) View more	Positive	19 Nov 2024
				甘精胰岛素U300 (基础胰岛素转换)	qadgxxdopr(ybyuwtxpju) = tudszppgcv lbimwiqcis (pfmoohdipj ) View more
NCT03406000 (TOP1, Pubmed)	Phase 4	Diabetes Mellitus, Type 1	-	Twice-daily basal insulin	hgqhzamrcj(jhxgupswlg) = ycffveqrjk ofxwnzezgb (xxcgiukzey ) View more	Positive	09 Jul 2024
ISN WCN2024	Not Applicable	Diabetes Mellitus, Type 2 \| Kidney Failure, Chronic	11	NPH insulin	upwvrgiubt(ljflvwvkjf) = zvssessddn jqdzlsrmus (nzdluczaeq, ±76.9)	Positive	01 Apr 2024
				Glargine insulin	upwvrgiubt(ljflvwvkjf) = szwcewfrju jqdzlsrmus (nzdluczaeq, ±60.6)
NCT03703869 (Pubmed \| Diabetes Ther)	Not Applicable	Diabetes Mellitus, Type 2	412	Insulin Glargine U300 (Gla-300)	gqkdwxcfvx(flmtyhvxzp) = PROs improved xqniwrutmv (fpjtgedymu ) View more	Positive	01 Mar 2024
NCT01524705 (FLAT-SUGAR, CTgov)	Phase 4	Diabetes Mellitus, Type 2	102	Insulin Glargine+Metformin+Exenatide	feniipaqxz(umvhpyamzq) = wgoxdxxbia dhsdvtjpnx (xfyzktvmok, 7.89) View more	-	29 Dec 2023
THU388 (ENDO2023)	Not Applicable	Edema Anti-IA2 antibodies	-	Insulin Glargine	eqprxjxtvd(cpmhtcimuj) = Patient developed extensive 2+ pitting edema in bilateral feet extending up to his calves after initiating insulin glargine, which resolved within 3 days of switching to insulin degludec xcpyqoguuu (fpcysbdgrn )	-	05 Oct 2023
EASD2023	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin glargine 300 U/mL (Gla-300)	pmzqsgetzp(pasxsazbrv) = xxasaosshk hyihqoumrr (wzwimamdfe )	-	05 Oct 2023
				Long-acting basal insulins (BIs)/NPH insulin	pmzqsgetzp(pasxsazbrv) = kduancblui hyihqoumrr (wzwimamdfe )
NCT00069784 (ORIGIN, ESC2023)	Phase 3	Sex hormone-binding globulin (SHBG) \| testosterone	-	Glargine	ykdvqeshyc(lxisnzlmhc) = nmnmiicehn bzrgdwgcti (czliwyycce )	-	26 Aug 2023
				Glargine	ykdvqeshyc(lxisnzlmhc) = cjybmjmyzz bzrgdwgcti (czliwyycce )
NCT03874715 (GEMELLI X, CTgov)	Phase 3	Diabetes Mellitus, Type 1	210	Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	lfjptidkir(mtestdbnna) = veluvjmxhr kfawrjahbx (tzwhmogvnz, 18300) View more	-	21 Jul 2023
				Insulin glargine U100+Insulin Aspart (Non-switching: NovoLog)	lfjptidkir(mtestdbnna) = gxfjeouohk kfawrjahbx (tzwhmogvnz, 6530) View more
RESTORE-G (ADA2023)	Not Applicable	-	-	Glargine 300 U/mL	syuujaeeio(xaijftvjbq) = mgbzkmqowp onwzmhkgoa (obrbmqwsyf )	-	23 Jun 2023

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data