Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee ® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee ® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential f (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Lilly's Insulin Glargine Biosimilar, Rezvoglar FDA Approves Lilly's Insulin Glargine Biosimilar, Rezvoglar
Rezvoglar is the second"biosimilar" and the third off-brand version of the long-acting analogue insulin, originally sold as Lantus.FDA Approvals (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - December 29, 2021 Category: Internal Medicine Tags: Diabetes & Endocrinology News Alert Source Type: news

Biocon and Viatris to distribute Insulin Glargine through Walgreens in US
While Viatris has commercialisation rights for the US, Canada, Australia, EU and others, Biocon will be able to commercialise the products in Japan and some emerging markets. Other global markets have been split among the two partners to serve the rest of the world. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 19, 2021 Category: Pharmaceuticals Source Type: news

' Twincretin' Beats Glargine for Diabetes in Pivotal Trial'Twincretin' Beats Glargine for Diabetes in Pivotal Trial
The"twincretin" tirzepatide scored another pivotal-trial win in published results from the SURPASS-4 trial, which compared the investigational agent to insulin glargine for treatment of type 2 diabetes.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - October 28, 2021 Category: Cardiology Tags: Diabetes & Endocrinology News Source Type: news

Biocon's interchangeable biosimilar Insulin glargine added on Express Scripts ’ largest formulary in US
The listing is expected to boost Biocon's biosimilar business, as inclusion of Semglee on Express Scripts' NPF will allow pharmacies to substitute the much cheaper Semglee for Sanofi's Lantus without having to consult the prescribing healthcare professional. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 21, 2021 Category: Pharmaceuticals Source Type: news

Semglee (Insulin Glargine Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 5, 2021 Category: Drugs & Pharmacology Source Type: news

Approval Of First Interchangeable Biosimilar, Semglee, Is Sign Of An Improving U.S. Biosimilars Market, Despite Challenges
On July 28th, the FDA approved the first interchangeable biosimilar, Semglee (long-acting insulin glargine), which implies that it can be automatically substituted at the pharmacy counter. This will usher in more competition into the insulin glargine market. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - August 1, 2021 Category: Pharmaceuticals Authors: Joshua Cohen, Contributor Tags: Healthcare /healthcare Innovation /innovation business pharma & Source Type: news

Correction: FDA-Generic Insulin story
In a story published July 28, 2021, about pharmacists being allowed to automatically substitute a cheaper, near-copy for Lantus brand insulin, The Associated Press erroneously reported that Lantus is a fast-acting insulin (Source: ABC News: Health)
Source: ABC News: Health - July 29, 2021 Category: Consumer Health News Tags: Health Source Type: news

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes
The U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. (Source: World Pharma News)
Source: World Pharma News - July 29, 2021 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

FDA Approves First Interchangeable Biosimilar Insulin FDA Approves First Interchangeable Biosimilar Insulin
Semglee is now both biosimilar to glargine and also interchangeable with Lantus, so it can be substituted at the pharmacy.FDA Approvals (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - July 29, 2021 Category: Drugs & Pharmacology Tags: Diabetes & Endocrinology News Alert Source Type: news

Biocon's Semglee gets USFDA approval; first interchangeable biosimilar product in US
“It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine,” Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 29, 2021 Category: Pharmaceuticals Source Type: news

FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
SILVER SPRING, Md., July 28, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 28, 2021 Category: Drugs & Pharmacology Source Type: news

What's Best for Diabetes After Metformin? GRADE Outdated at Outset What's Best for Diabetes After Metformin? GRADE Outdated at Outset
The GRADE trial compared four different agents as add-ons to metformin for type 2 diabetes, and while liraglutide and insulin glargine fared best, the study is already outdated, said one commentator.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 30, 2021 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

Once-Weekly Insulin Icodec Promising for Type 2 Diabetes
FRIDAY, Sept. 25, 2020 -- For patients with type 2 diabetes, once-weekly insulin icodec has glucose-lowering efficacy comparable to once-daily insulin glargine, according to a study published online Sept. 22 in the New England Journal of Medicine to... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 25, 2020 Category: Pharmaceuticals Source Type: news

Mylan and Biocon Biologics Announce Launch of Semglee(TM) (insulin glargine injection) in the U.S. to Expand Access for Patients Living with Diabetes
Semglee available in vial and pen presentations at a 65% discounted list price, the lowest available for a long-acting insulin glargine on the market HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, Aug. 31, 2020 -- (Healthcare Sales & Market... Biopharmaceuticals, Generics, Product Launch Mylan, Biocon Ltd, Biocon Biologics India, Semglee, diabetes, insulin glargine (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 31, 2020 Category: Pharmaceuticals Source Type: news