A 26-week, Randomized, Open-label, Parallel-group Comparison of SAR341402 Mix 70/30 to NovoMix®30 in Adult Patients with Diabetes Mellitus Using Pre-mix Insulin Analogs - GEMELLI M

Start Date03 Jun 2019

Sponsor / Collaborator

Sanofi-Aventis Recherche & Développement SA

NCT03874715

/ CompletedPhase 3

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).

Start Date11 Mar 2019

Sponsor / Collaborator

Sanofi

NCT03436498

/ CompletedPhase 1

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].

Start Date10 May 2018

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Insulin aspart biosimilar(Sanofi)

100 Translational Medicine associated with Insulin aspart biosimilar(Sanofi)

100 Patents (Medical) associated with Insulin aspart biosimilar(Sanofi)

Literatures (Medical) associated with Insulin aspart biosimilar(Sanofi)

01 Jul 2025·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

Author: Barnes, Cathy ; Nakhle, Samer ; Wernicke-Panten, Karin ; Al-Karadsheh, Amer ; Pierre, Suzanne ; Teichert, Lenore ; Mandry, Jose ; Mukherjee, Bhaswati ; Rotthaeuser, Baerbel ; 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.

23 Jun 2025·MEDICAL LETTER ON DRUGS AND THERAPEUTICS

In brief: Merilog - a NovoLog biosimilar.

Article

01 Feb 2024·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

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

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 (Cmax) 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 Cmax 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.

News (Medical) associated with Insulin aspart biosimilar(Sanofi)

07 Mar 2025

·www.prnewswire.com

February Recap: 15 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including business strategies shaping the future of healthcare and three major health news trends. NEW YORK, March 7, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, February 2025. Photos provided by CINDE, Sebela Pharmaceuticals Inc and WeWard. BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value "Our BD 2025 strategy has transformed the company into a faster-growing, more profitable organization positioned at the forefront of long-term growth trends in health care," said Tom Polen, chairman, CEO and president of BD. FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women's Health Inc. "This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options," said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. Lilly launches additional Zepbound vial doses and offers new savings for self-pay patients Self-pay patients with obesity now have additional Zepbound vial options, including 2.5 mg, 5 mg, 7.5 mg and 10 mg doses. In addition to expanding the doses available, Lilly has reduced prices of the 2.5 mg and 5 mg vials to $349 per month and $499 per month, respectively. Costa Rica Continues to Strengthen Its Position as a Leading Hub for Life Sciences Companies Since 2017, Costa Rica's medical device exports have grown at an average annual rate of 18%, surpassing $8 billion in 2024. This rapid expansion has positioned the country as Latin America's second-largest exporter of medical devices and the fifth-largest supplier of these products to the United States. The Cigna Group Launches Actions to Drive Positive Change for Customers and Patients "The health care system in America needs to be better, and we have challenged ourselves to help lead and drive systemic change," said David M. Cordani, chairman and CEO of The Cigna Group. "We do a lot of good for many people, but we need to do better for everyone. We are committed to implementing tangible actions across our company to help drive better health outcomes and health care experiences." Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia Troriluzole has a well-established safety profile and if approved, would be the first and only FDA-approved treatment for Spinocerebellar Ataxia (SCA), a rare, genetic, life-threatening neurodegenerative disease. AbbVie and Xilio Therapeutics Announce Collaboration and Option Agreement to Develop Novel Tumor-Activated Immunotherapies The collaboration will combine AbbVie's oncology expertise and Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers. Solventum Announces Sale of its Purification & Filtration Business to Thermo Fisher Scientific Inc. for $4.1B "We are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions," said Bryan Hanson, Solventum CEO. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. Chan Zuckerberg Initiative Launches Billion Cells Project with 10x Genomics and Ultima Genomics to Advance AI in Biology "Biology not only needs more data – the field needs more data faster and in interoperable formats to support AI models that address specific problems, and this project represents a unique approach to scaling and standardizing scientific outputs for AI and more," said Jonah Cool, Cell Science Senior Science Program Officer at CZI. Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's DBS is similar to a cardiac pacemaker, but for the brain. It uses a surgically implanted neurostimulator via a minimally invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders. Illumina unveils first-of-its-kind spatial transcriptomics technology Illumina has announced a new spatial technology program that will empower researchers to map complex tissues and understand cellular behavior at an unprecedented scale. "With this innovation, we are setting a new bar that will drive the next wave of scientific discoveries and unlock a deeper understanding of biology," said Steve Barnard, PhD, chief technology officer of Illumina. U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options "As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health," said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance." U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy Since receiving a permanent J-code in April 2024, IZERVAY has had month-over-month growth in the U.S. with more than 210,000 vials distributed through the end of December 2024. Texas Children's Hospital and UT MD Anderson Announce Joint Venture to End Childhood Cancer The partnership forms the nation's largest complement of pediatric subspecialty care and services to children diagnosed with all types of cancer within a single entity, with operations planned to launch in early 2026. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in February, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. American Heart Month: February featured extensive focus on cardiovascular health with diverse awareness initiatives across multiple sectors. Prevention took center stage as Venus Williams invested in the WeWard walking app, Planet Fitness promoted strength training accessibility, and Texas advocates rallied for cardiac emergency response plans in schools during Heart Month. Former Miss Ohio Lindsay Davis joined cardiologists to raise awareness for hypertrophic cardiomyopathy, while NFL Hall of Famer Jerome Bettis partnered with the CDC Foundation's Live to the Beat campaign to address hypertension's impact on Black adults. HIMSS25: The healthcare technology sector generated significant wire activity surrounding the 2025 HIMSS Global Health Conference in Las Vegas (March 3-6). AI innovation dominated announcements, with companies unveiling solutions ranging from Kontaktio's agentic AI for care orchestration to Amtelco's AI-powered virtual agent Ellie. Industry collaboration also emerged as a key theme, with major EHR providers MedAllies, Epic, Netsmart, and eClinicalWorks announcing a joint demo, while Microsoft partnered with Canary Speech to advance digital health transformation. Rare Disease Day: As Rare Disease Day approached on Feb. 28, PR Newswire distributed numerous announcements highlighting advocacy efforts and research breakthroughs. The National Organization for Rare Disorders (NORD) released a critical report on newborn screening programs and later partnered with Paramount Pictures to amplify awareness. The Rare Disease Diversity Coalition prepared to host its 2nd Annual RISE Awards, while NFL legends joined advocates from 49 states for the 14th annual Rare Disease Week on Capitol Hill. Additional mainstream support for the rare disease community came from the New York Stock Exchange with a special pre-market update commemorating Rare Disease Day. Looking ahead: This March, women's health themes will likely dominate coverage surrounding International Women's Day (March 8) and throughout Women's History Month. PR Newswire also anticipates significant activity around National Nutrition Month, with releases spotlighting dietary innovations and wellness campaigns. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapy

21 Feb 2025

·www.prnewswire.com

Weekly Roundup: 15 Health Press Releases You Need to See

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including an AI-powered Primary Care as a Service™ offering and H5N1 (Bird Flu) testing updates. NEW YORK, Feb. 21, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, Feb. 17-21, 2025. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. Lumeris Introduces Tom™, an AI-Powered Breakthrough to Transform Primary Care Lumeris addresses the imbalance between primary care demand and supply with Tom™, the industry's first AI-powered Primary Care as a Service™ designed to support overburdened physicians. Tom autonomously executes next-best actions, including scheduling appointments, monitoring medication adherence, conducting post-discharge outreach, and sharing patient education. Employer-Sponsored GLP-1 Coverage Becomes Critical for Talent Retention and Acquisition, New 9amHealth Survey Finds Employer-sponsored coverage of these medications has more than doubled, rising from 30% to 63%. However, for the 25% of employees who want access but don't have it, affordability remains a challenge. In fact, 31% would change jobs to gain coverage (up from 21%). Pretorian Labs to Test Human Patients for H5N1 (Bird Flu) Pretorian Labs is one of the first in the US to test human patients for H5N1 virus (Bird Flu), offering testing to all providers and facilities nationally who are existing or new clients of Pretorian Labs. "Ohio leads the nation in poultry losses as the bird flu continues to spike. It's logical for us to have the capability to test for this virus on our human patients," said Carmen Melillo, Chief Executive Officer of Pretorian Labs. New ACS Study Shows Cancer Mortality Rates Among Black People Declining, but Remain Higher Than Other Racial and Ethnic Groups "Overall declines in cancer mortality rates in Black people largely reflect behavioral changes…as well as advances in treatment and earlier detection for some cancers," said Rebecca Siegel, senior scientific director, surveillance research at the American Cancer Society, and senior author of the report. "Yet, this population persistently experiences a much higher mortality burden than other racial and ethnic groups for many cancers. We must reverse course." Ed DeVaney named President of CVS Caremark "I am honored to take on this role and to work with our dedicated colleagues who are focused on making prescription drugs more affordable and delivering better care to everyone we are privileged to serve," said DeVaney. NFL Legends Join Advocates from 49 States for 14th Annual Rare Disease Week on Capitol Hill The EveryLife Foundation for Rare Diseases will welcome retired NFL legends and first-time advocates Josh Andrews and Art Still to the upcoming Rare Disease Week on Capitol Hill in Washington, D.C. During their time in D.C., participants – whether first timers or seasoned advocates – are educated on policy proposals impacting the rare disease community and provided opportunities to advocate for policy changes directly to their Members of Congress. Bio-Techne Announces Release of GMP TcBuster Non-Viral Genome Engineering System The TcBuster System has been widely used by researchers to introduce large cargo genetic modifications in a range of cell types. The new GMP transposase will offer a clearer path to clinic for applications in gene edited cell therapies, such as CAR-T or TCR generation. Texas Children's Hospital and UT MD Anderson Announce Joint Venture to End Childhood Cancer The partnership forms the nation's largest complement of pediatric subspecialty care and services to children diagnosed with all types of cancer within a single entity, with operations planned to launch in early 2026. Breaking Barriers: The Black Therapy Network is Closing the Mental Health Gap for Black Americans Dedicated to normalizing therapy in the Black community, The Black Therapy Network (BTN) launches to ensure culturally competent therapy is accessible, affordable, and stigma-free. BTN is built for Black clients by Black professionals, ensuring a deeper understanding of cultural experiences and identity-related stressors. ZERO Prostate Cancer Launches Bold $20 Million 'Blitz The Barriers' Initiative to Close Gaps in Prostate Cancer Survival in Highest-Risk Communities A $7.5M commitment from Novartis as Lead Founding Partner will launch Blitz the Barriers, a prostate cancer awareness initiative aimed to save lives by addressing critical disparities in prostate cancer outcomes, especially among Black men, Veterans, and rural underserved communities. Illumina unveils first-of-its-kind spatial transcriptomics technology Illumina has announced a new spatial technology program that will empower researchers to map complex tissues and understand cellular behavior at an unprecedented scale. "With this innovation, we are setting a new bar that will drive the next wave of scientific discoveries and unlock a deeper understanding of biology," said Steve Barnard, PhD, chief technology officer of Illumina. SpringWorks Therapeutics and Jewelry Designer Jennifer Fisher Team Up to Encourage People with Desmoid Tumors to Take Action Before Their Tumor Takes Over Desmoid tumors are aggressive and invasive tumors that can arise in any part of the body. Their tendril-like growths can wrap around nearby tissue and compress vital organs and nerves. This can cause severe and chronic pain, loss of function, reduced mobility, disfigurement, and anxiety. Highmark expands virtual care access with Virtual Pelvic Health powered by Sword Health To help those experiencing pelvic health dysfunction, Highmark has added Virtual Pelvic Health powered by Sword Health as a benefit at no additional cost to eligible health plan members. "…Our members can now improve their pelvic strength more discreetly, safely and conveniently in the comfort of their own homes," said Karen Hanlon, EVP, chief operating officer, Highmark Health. European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine KOSTAIVE, the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission, represents significant advancement in vaccine technology and demonstrates superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalVaccine

19 Feb 2025

·www.drugs.com

FDA Approves Merilog, First Rapid-Acting Insulin Biosimilar for Patients With Diabetes

WEDNESDAY, Feb. 19, 2025 -- The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus . Merilog is a rapid-acting human insulin analog and the first rapid-acting insulin biosimilar product approved by the FDA. Administering Merilog subcutaneously five to 10 minutes before mealtime helps improve glycemic control in patients with diabetes . Both a 3-mL single-patient-use prefilled pen and a 10-mL multiple-dose vial are included in this approval. Serious side effects reported with Merilog include hypoglycemia, severe allergic reactions, and low potassium levels in the blood. Common side effects include injection site reactions, itching, rash, skin thickening or pitting at the injection site, weight gain, and swelling of hands and feet. "The FDA has now approved three biosimilar insulin products to treat diabetes," Peter Stein, M.D., director of the Office of New Drugs in the FDA Center for Drug Evaluation and Research, said in an agency press release. "Today’s approval highlights our continued efforts to improve the efficiency of the biosimilar approval process to help support a competitive marketplace and increase options for costly treatments, like insulin. Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA." Approval of Merilog was granted to Sanofi-Aventis. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug Approval

100 Deals associated with Insulin aspart biosimilar(Sanofi)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10AD05 A10AB05	DB01306

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Japan	Sanofi KK	23 Mar 2021
Diabetes Mellitus	European Union	Sanofi Winthrop Industrie SA	25 Jun 2020
Diabetes Mellitus	Iceland	Sanofi Winthrop Industrie SA	25 Jun 2020
Diabetes Mellitus	Liechtenstein	Sanofi Winthrop Industrie SA	25 Jun 2020
Diabetes Mellitus	Norway	Sanofi Winthrop Industrie SA	25 Jun 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	United States	Sanofi	02 Aug 2017
Diabetes Mellitus, Type 1	Phase 3	Japan	Sanofi	02 Aug 2017
Diabetes Mellitus, Type 1	Phase 3	Finland	Sanofi	02 Aug 2017
Diabetes Mellitus, Type 1	Phase 3	Germany	Sanofi	02 Aug 2017
Diabetes Mellitus, Type 1	Phase 3	Hungary	Sanofi	02 Aug 2017
Diabetes Mellitus, Type 1	Phase 3	Poland	Sanofi	02 Aug 2017
Diabetes Mellitus, Type 1	Phase 3	Russia	Sanofi	02 Aug 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03874715 (GEMELLI X, Pubmed \| J Diabetes Sci Technol)	Phase 3	Diabetes Mellitus, Type 1	210	SAR341402 Insulin Aspart	yexvlabyji(huggzrjren): LS mean difference = 0.23 View more	Positive	01 Jul 2025
				Originator Insulin Aspart
FDA_CDER Manual	Not Applicable	Diabetes Mellitus, Type 2	176	Insulin aspart + NPH	qwntxjdmjh(tkxawzqdfe) = hicrpnjhot tzpbccaplj (pvzivgltbp, 1.0)	Positive	14 Feb 2025
				Regular Human Insulin + NPH	qwntxjdmjh(tkxawzqdfe) = zlselnjznl tzpbccaplj (pvzivgltbp, 0.8)
FDA_CDER Manual	Not Applicable	Diabetes Mellitus, Type 1	283	Insulin aspart + NPH (Pediatric)	cxrgwopfhs(fxyucwypmg) = dimpxyjzvn vuuixbsifi (rpspkiilbl, 1.0)	Positive	14 Feb 2025
				Regular Human Insulin + NPH (Pediatric)	cxrgwopfhs(fxyucwypmg) = oncosnglag vuuixbsifi (rpspkiilbl, 1.1)
FDA_CDER Manual	Not Applicable	Diabetes Mellitus, Type 1	-	Insulin aspart + NPH (Adults)	iiiyzazvll(cynqpdgztm) = eskivomfla dosnanconq (avdninhaxi, 0.8)	Positive	14 Feb 2025
				Regular Human Insulin + NPH (Adults)	iiiyzazvll(cynqpdgztm) = indotncsal dosnanconq (avdninhaxi, 0.8)
NCT03874715 (GEMELLI X, CTgov)	Phase 3	Diabetes Mellitus, Type 1	210	Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	wianrduott(iicnhsqykw) = pgtiwemswe fyyfvdxvwu (ldnmcmiobt, 18300) View more	-	21 Jul 2023
				Insulin glargine U100+Insulin Aspart (Non-switching: NovoLog)	wianrduott(iicnhsqykw) = bqlmgilnho fyyfvdxvwu (ldnmcmiobt, 6530) View more
NCT03211858 (GEMELLI 1, Pubmed) Manual	Phase 3	Diabetes Mellitus	597	Insulin Glargine+SAR341402	oiunjyhois(xhrcgesmfm) = vaarjinsxj kbpuanchbn (vhuqwxwwgk )	Similar	01 Feb 2020
				Insulin Glargine+Originator Insulin Aspart	oiunjyhois(xhrcgesmfm) = jhvmzjjewt kbpuanchbn (vhuqwxwwgk )
NCT03211858 (GEMELLI1 \| GEMELLI 1, CTgov)	Phase 3	Diabetes Mellitus, Type 1	597	Insulin glargine (HOE901)+Insulin aspart (SAR341402)	qikmofxpkl(wxqklafxdi) = akoithazpm jgzuaqfnvj (mhipiudsre, 0.042) View more	-	08 Aug 2019
				Insulin glargine (HOE901)+NovoLog (NovoLog/NovoRapid)	qikmofxpkl(wxqklafxdi) = znqtsoirik jgzuaqfnvj (mhipiudsre, 0.041) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

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.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis