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Business Standard
16-07-2025
- Business
- Business Standard
Biocon Biologics expands diabetes portfolio with FDA approval for Kirsty
Biocon Biologics, a subsidiary of biopharmaceutical company Biocon, said on Wednesday that the US Food and Drug Administration (FDA) has approved Kirsty (Insulin Aspart), the 'first and only' interchangeable biosimilar to NovoLog (Insulin Aspart). Kirsty is a rapid-acting human insulin for improving glycaemic control in adults and paediatric patients with diabetes mellitus. It will be available as a single-patient-use prefilled pen for subcutaneous administration and as a multi-dose vial for both subcutaneous and intravenous use. (An interchangeable biosimilar can be swapped for its original biologic at the pharmacy without prescriber approval.) 'The FDA approval of Kirsty, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the US, is a significant step forward in our efforts to make insulin more accessible and affordable,' said Shreehas Tambe, chief executive officer and managing director of Biocon Biologics. 'It builds on the foundation we laid with Semglee, reinforcing our commitment to scientific excellence and patient-centric innovation. With Kirsty, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care,' he said. The approval for Kirsty strengthens Biocon Biologics' biosimilar insulin portfolio, which includes Semglee Insulin, the first FDA-approved interchangeable biosimilar. Kirsty has been available in Europe and Canada since 2022. Biocon Biologics in March announced a strategic collaboration with Civica Inc. to improve access and affordability of Insulin Aspart in the US. The company has also previously received US FDA approvals for biosimilars, including Ogivri (biosimilar Trastuzumab), Fulphila (Pegfilgrastim), and Semglee (Insulin Glargine).
Business Standard
16-07-2025
- Business
- Business Standard
Biocon arm gets USFDA approval for insulin, Kirsty
Biocon announced that its subsidiary, Biocon Biologics, has received US Food and Drug Administration (USFDA) approval for Kirsty (Insulin Aspart-xjhz) 100 units/ml, to improve glycemic control in adults and pediatric patients with diabetes mellitus. Kirsty is biosimiler to Novolog. It is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. It will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. The FDA approval of KIRSTY expands Biocon Biologics biosimilar insulin portfolio, which also includes the first approved interchangeable biosimilar, Semglee (Insulin Glargine-yfgn Injection). KIRSTY has been available in Europe and Canada since 2022. According to IQVIA, there are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter of them being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic. Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024. Shreehas Tambe, CEO & managing director, Biocon Biologics, said: The FDA approval of Kirsty, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the U.S., is a significant step forward in our efforts to make insulin more accessible and affordable. It builds on the foundation we laid with Semglee, reinforcing our commitment to scientific excellence and patient centric innovation. With Kirsty, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care. Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions like diabetes, cancer, and autoimmune diseases. The companys consolidated net profit surged 154.2% to Rs 344.50 crore on a 12.8% jump in net sales to Rs 4,358.10 crore in Q4 FY25 over Q4 FY24. The counter jumped 2.90% to settle at Rs 390.20 on the BSE.
Time of India
16-07-2025
- Business
- Time of India
Biocon Biologics gets USFDA nod for diabetes medication
New Delhi: Biocon Biologics on Wednesday said it has received approval from the US health regulator to market a diabetes treatment medication. The company, a unit of Biocon Ltd , has received approval from the US Food and Drug Administration (USFDA) for Kirsty as the first and only interchangeable biosimilar to NovoLog ( Insulin Aspart ). Kirsty is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like This Could Be the Best Time to Trade Gold in 5 Years IC Markets Learn More Undo The medication will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use, Biocon said in a statement. The approval expands Biocon Biologics' biosimilar insulin portfolio, which also includes the interchangeable biosimilar, Semglee (Insulin Glargine-yfgn Injection). Live Events An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP). Kirsty has been available in Europe and Canada since 2022. As per the company, there are 38.4 million people with diabetes in the US, around 11.6 per cent of the total population, with nearly a quarter of them being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic, it added. According to IQVIA, sales of Insulin Aspart in the US stood around USD 1.9 billion in 2024. Shares of Biocon were trading 1.44 per cent up at Rs 395.80 apiece on the BSE.
