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
Biocon Biologics launches Semglee, drug to control high blood sugar, in US
To encourage broad patient access to this important medicine, Mylan is offering Semglee at a wholesale acquisition cost (WAC)[1] of $147.98 per package of five (5) 3ml pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market, said Biocon in a press release. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 30, 2020 Category: Pharmaceuticals Source Type: news
Semglee (Insulin Glargine Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - June 18, 2020 Category: Drugs & Pharmacology Source Type: news
Early Data on Once-Weekly Insulin; Will it Transform Treatment? Early Data on Once-Weekly Insulin; Will it Transform Treatment?
With similar efficacy and safety to insulin glargine U100, if findings are confirmed in phase 3 and product is approved, it could be the first-ever weekly insulin.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - June 15, 2020 Category: Drugs & Pharmacology Tags: Diabetes & Endocrinology News Source Type: news
' Biosimilar' Insulin Glargine, Semglee, Approved for Diabetes in US'Biosimilar' Insulin Glargine, Semglee, Approved for Diabetes in US
Semglee, marketed by Mylan Pharmaceuticals, has been approved by the FDA for adults and children with type 1 diabetes and adults with type 2 diabetes.FDA Approvals (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - June 13, 2020 Category: Internal Medicine Tags: Diabetes & Endocrinology News Alert Source Type: news
FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 11, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 11, 2020 Category: Drugs & Pharmacology Source Type: news
Biocon gets US FDA nod to launch insulin glargine
The product branded as Semglee has an identical amino acid sequence to Sanofi ’s Lantus® and is approved for the same indications. This is the third biologics that Biocon will launch in the US. Semglee was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a) in accordance with the Biologics Price Competition and Innov ation Act in line with other insulin products. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 11, 2020 Category: Pharmaceuticals Source Type: news
Lannett Provides Update On Clinical Advancement Of Biosimilar Insulin Glargine, Following FDA Meeting
Company Anticipates Biosimilar Application to be Submitted By End of Calendar Year 2022
PHILADELPHIA, June 11, 2020 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (NYSE: LCI) today said that representatives from the company spoke wi... Biopharmaceuticals, Generics, FDA Lannett, biosimilar, insulin, glargine (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 11, 2020 Category: Pharmaceuticals Source Type: news
Biocon's partner Mylan gets favourable ruling from US patent authority for 4 devices
"We are extremely pleased with the US PTAB's ruling in favour of our partner Mylan for four device patents of Sanofi's Lantus SoloSTAR. This strengthens our resolve to provide a high quality affordable Insulin Glargine to diabetic patients in the US and generate savings for their healthcare system," Biocon Biologics CEO and MD Christiane Hamacher said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 31, 2020 Category: Pharmaceuticals Source Type: news
Biocon says probe on Malaysia manufacturing unit ends
“This is to inform you that Biocon Sdn Bhd, a subsidiary of Biocon, has received the EIR from the USFDA for the pre-approval inspection of its insulins manufacturing facility in Malaysia, for Insulin Glargine. The inspection was conducted between Feb 10 and 21, 2020,” said the company spokespers on in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 31, 2020 Category: Pharmaceuticals Source Type: news
Biocon, Mylan win US court ruling in favour of insulin Glargine
US District Court of New Jersey found the device patent claims (US Patent No. 9526844) asserted by Sanofi against Biocon and Mylan ’s insulin Glargine product ‘not infringed’ and ‘invalid’ for lack of written description, said Biocon in a press statement. Semglee is co-developed with Mylan in the US. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 10, 2020 Category: Pharmaceuticals Source Type: news
Biocon gets 3 USFDA observations for insulin facility in Malaysia
USFDA had conducted a pre-approval inspection of Biocon's subsidiary Biocon Sdn BHd's manufacturing facility in Malaysia for Insulin Glargine between February 10 and 21. "At the conclusion of the inspection, the agency issued a Form 483 with three observations which we believe are procedural in nature," a Biocon spokesperson said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 21, 2020 Category: Pharmaceuticals Source Type: news
FDA Expands Use of Toujeo to Childhood Type 1 Diabetes FDA Expands Use of Toujeo to Childhood Type 1 Diabetes
First approved for US adults with type 1 and type 2 diabetes in 2015, Toujeo (insulin glargine 300 units/mL injection) may now be used in children as young as 6 years with type 1 diabetes.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - December 3, 2019 Category: Endocrinology Tags: Diabetes & Endocrinology News Alert Source Type: news
FDA Expands Use of Toujeo to Childhood Diabetes FDA Expands Use of Toujeo to Childhood Diabetes
First approved for US adults in 2015, Toujeo (insulin glargine 300 units/mL injection) may now be used in children as young as 6 years with type 1 or type 2 diabetes.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - December 3, 2019 Category: Endocrinology Tags: Diabetes & Endocrinology News Alert Source Type: news
New Focus for Boehringer Ingelheim and Lilly Alliance
Boehringer Ingelheim and Lilly modernise alliance to focus full expertise on Jardiance ®Alliance to focus combined expertise and investment to maximise Jardiance ®for people with type 2 diabetes, heart failure, and chronic kidney diseaseAlliance to continue to include three product families – empagliflozin, linagliptin and insulin glargine (Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - November 4, 2019 Category: Research Source Type: news
