INSULIN GLARGINE
Game changer: California launches $11 state brand to slash Diabetes costs
California is set to launch its own low cost insulin under the CalRx beginning from January 1, 2026, representing a major step in the state’s attempt to minimize prescription drug prices. Partnering with nonprofit Civica and Biocon Biologics, the program will sell insulin pens at $11 each or $55 per five-pack, no prescription needed. Governor Gavin Newsom stated it as “access on the basis of affordability.”
Biocon Biologics expands collaboration with Civica to supply affordable insulin in US
Biocon Biologics is expanding its partnership with Civica. This new agreement will bring affordable Insulin Glargine to patients in the United States. Biocon Biologics will manufacture the insulin. Civica will then distribute and sell it under its own label. This move aims to improve access to essential diabetes medication for more people.
Lilly's weight-loss pill shows better blood sugar control in late-stage trials
Eli Lilly's experimental oral weight-loss drug, orforglipron, demonstrated superior blood sugar control in diabetic patients across two late-stage trials. The drug, designed to mimic the GLP-1 hormone, showed significant A1C reductions and weight loss, potentially setting a new standard of care for type 2 diabetes.
Biocon sees GLP-1 weight-loss therapy as a future growth driver
Biocon will strengthen its insulin business while advancing in GLP-1 therapies, with semaglutide in Phase-III trials and a planned 2027 India launch. CEO Shreehas Tambe said both portfolios are complementary. Biocon aims to leverage its insulin experience for GLP-1 success, following US FDA approval for insulin aspart and India approval for liraglutide. External risks remain a key concern.
Biocon shares surge 3% as subsidiary obtains USFDA approval for diabetes drug
Biocon share price jumped after its subsidiary Biocon Biologics received USFDA approval for Kirsty, a rapid-acting insulin biosimilar. This makes it the first interchangeable version of NovoLog in the U.S., expanding Biocon’s insulin portfolio amid a growing diabetes burden in the country.
Eris Lifesciences enters licensing deal with Biocon for insulin glargine
The launch of long acting insulin glargine will help Eris to fill the gap in its insulin portfolio. Eris derives more than half of its revenues from cardio-metabolic therapeutic segment, and has adopted a “Full Service” approach to diabetes management with a comprehensive range of oral anti-diabetics, insulins, and glucose testing devices.
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Biocon Biologics set to reap biosimilar insulin glargine opportunity in US
Drugmaker Biocon is banking on the ramp-up of interchangeable biosimilar insulin glargine expecting the product to boost the revenue and profit growth in the next several quarters, primarily from the US market.
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.
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.
Biocon Biologics interchangeable insulin Semglee gets US FDA approval
Biocon partnered with global healthcare company Viatris Inc to develop Semglee, the first interchangeable biosimilar product approved in the United States to treat diabetic patients.
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.
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 Innovation Act in line with other insulin products.
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.
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 spokesperson in a statement.
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.
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.
Biocon, Mylan launch insulin biosimilar in Australia
The biotechnology major and pharmaceutical company Mylan N V announced the launch of their insulin biosimilar Semglee.
USFDA issues response letter for new drug application for insulin glargine: Biocon
Biocon is confident of addressing these observations through a corrective and preventive action plan in a timely manner, it added.
Biocon's Malaysian arm gets EU GMP certification for insulin manufacturing facility
The integrated insulins facility in Malaysia manufactures drug substance and drug products in vials, cartridges, and insulin delivery devices was inspected in May 2019.
Mylan-Biocon’s insulin biosimilar faces FDA hurdle
Firms have been asked to share details about a change in the manufacturing site for glargine from Bengaluru to a new facility in Malaysia.
European Medicines Agency accepts marketing application of Biocon, Mylan product
Mylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients.
Biocon's partner firm launches diabetes product in Japan
In March this year, Biocon received approval from the Japanese health authority to sell its biosimilar product Insulin Glargine.
Biocon's biosimilars progress
Analysts gave a thumbs up to Biocon after the company said its copy of biopharmaceutical insulin glargine met the primary targets, which in effect takes the product closer to regulatory filings in the US.
Approval for insulin biosimilar in Japan a milestone for Biocon: Kiran Mazumdar Shaw, Biocon
This will also help Biocon enter the US and European markets in the near future
Biocon gets nod to sell its diabetes product 'Insulin Glargine' in Japan
Biocon has received approval from the Japanese health authority to sell its biosimilar product 'Insulin Glargine' in that country.
Biocon targets emerging, developed markets with biosimilars
"Biocon aims to provide high quality biosimilars to patients across the world, both in emerging and developed markets," Kiran Mazumdar-Shaw said.
Biocon rallies intraday after getting approval for insulin Glargine in Mexico, but ends in red
Biocon rallied a little over 3% in trade on Friday, after the biotechnology major said that it has received approval for its insulin Glargine
Biocon gets approval for insulin Glargine in Mexico
Galactus by PiSA is the first insulin Glargine to be approved in Mexico as per the biocomparable approvals pathway defined in 2012, it added.
Lupin inks pact with South Korean firm to launch diabetes drug
As per the strategic distribution pact inked between the two companies, Mumbai-based Lupin will launch LG Life Sciences' Insulin Glargine.
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