Latest news with #InsulinAspart-xjhz
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Business Standard
16-07-2025
- Business
- Business Standard
Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty
Bengaluru-based Biocon's subsidiary, Biocon Biologics Limited (BBL), announced today that the US Food and Drug Administration (FDA) has approved Kirsty (Insulin Aspart-xjhz) 100 units/mL, as the first and only interchangeable biosimilar to NovoLog (Insulin Aspart). Kirsty is a rapid-acting human insulin analogue indicated 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. Shreehas Tambe, Chief Executive Officer and Managing Director, BBL, said: '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. 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.' The FDA approval of Kirsty further strengthens Biocon Biologics' biosimilar insulin portfolio, which also includes Semglee Insulin, the first FDA-approved interchangeable biosimilar. Kirsty has been available in Europe and Canada since 2022. In March, Biocon Biologics announced a strategic collaboration with Civica, Inc. to improve access and affordability of Insulin Aspart in the United States. The company has also previously received US FDA approvals for several biosimilars, including Ogivri (biosimilar Trastuzumab), Fulphila (biosimilar Pegfilgrastim), and Semglee (biosimilar Insulin Glargine). Biocon Biologics supplies recombinant human insulin and Insulin Glargine, providing over 9.2 billion doses of insulin globally with a broad portfolio comprising basal, mixed and rapid-acting insulins. Globally, Biocon Biologics serves over 5.8 million patients annually and offers a comprehensive portfolio of approved and pipeline biosimilars across multiple therapeutic areas. This includes eight biosimilars in the United States and seven in Canada, with a robust pipeline of 20 biosimilar assets, encompassing insulins and monoclonal antibodies. An estimated 38.4 million people in the United States — approximately 11.6 per cent of the population — are living with diabetes, with nearly a quarter remaining undiagnosed. Additionally, 97.6 million Americans have been identified as prediabetic. According to IQVIA, US sales of Insulin Aspart reached approximately $1.9 billion in 2024.
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.
Economic Times
16-07-2025
- Business
- Economic Times
Biocon shares surge 3% as subsidiary obtains USFDA approval for diabetes drug
Biocon shares surged 3% to an intraday high of Rs 401.55 on the BSE on Wednesday, after its subsidiary, Biocon Biologics, secured the U.S. Food and Drug Administration (FDA) approval for Kirsty (Insulin Aspart-xjhz), 100 units/mL. ADVERTISEMENT This marks a significant milestone as Kirsty is the first and only interchangeable biosimilar to NovoLog (Insulin Aspart) in the United States. Kirsty, a rapid-acting human insulin analogue, is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. It will be available in a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. This FDA approval significantly expands Biocon Biologics' biosimilar insulin portfolio in the U.S., which already includes Semglee (Insulin Glargine-vfgn Injection), the first approved interchangeable biosimilar, available in Europe and Canada since news comes as the U.S. faces a substantial diabetes burden, with 38.4 million people diagnosed, representing approximately 11.6% of the total population. A significant portion, nearly a quarter, remain undiagnosed, and an additional 97.6 million Americans are identified as U.S. market for Insulin Aspart alone saw approximately $1.9 billion in sales in 2024. ADVERTISEMENT Biocon Biologics is already a global leader in biosimilars and insulin production, ranking among the top three global players for rh-Insulin and Insulin Glargine. The company has provided over 9.2 billion doses of insulin globally, with a broad portfolio of basal, mixed, and rapid-acting insulins. Globally, Biocon Biologics serves over 5.8 million patients annually and boasts a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies. ADVERTISEMENT Also read: Dolly Khanna bets on this smallcap stock with 1.5% stake purchase in June quarter This includes eight products in the United States and seven in Canada, with a robust portfolio of 20 biosimilar assets spanning multiple therapy areas, including insulins and monoclonal antibodies. ADVERTISEMENT On Tuesday, Biocon shares closed 3% higher at Rs 390.20 on the BSE. (Disclaimer: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times) (You can now subscribe to our ETMarkets WhatsApp channel)
News18
16-07-2025
- Business
- News18
Stocks To Watch: Tech M, ITC Hotels, HDFC Life, HDB Financial, Bajaj Finserv, And Others
Last Updated: Stocks to watch: Shares of firms like Tech M, ITC Hotels, HDFC Life, HDB Financial, Bajaj Finserv, and others will be in focus on Wednesday's trade Stocks to Watch on July 16, 2025: Markets saw some relief on Tuesday, edging slightly higher after four consecutive sessions of decline. In today's trade, shares of HDFC Life, HDB Financial, Tech Mahindra, Dixon Tech, ITC Hotels, and others will be in focus due to various news developments and first-quarter results. Tech Mahindra, ITC Hotels, Angel One Shares of Tech Mahindra, ITC Hotels, and Angel One will be in focus as these companies are set to announce their Q1 results. HDFC Life The company reported a 14.4% year-on-year increase in net profit for Q1 FY26, rising to Rs 547 crore from Rs 478 crore in the same period last year. HDB Financial HDB Financial Services recorded a slight decline in net profit for Q1 FY26, with profit after tax at Rs 568 crore, down 2% from Rs 582 crore in the corresponding quarter of the previous year. Dixon Technology Bajaj Finserv The Insurance Regulatory and Development Authority of India (IRDAI) approved the transfer of a 26% equity stake held by Allianz SE in Bajaj Allianz General Insurance and Bajaj Allianz Life Insurance to Bajaj Finserv, Bajaj Holdings & Investment (a promoter), and Jamnalal Sons (a promoter group entity). Just Dial The local search engine reported a 13% year-on-year rise in net profit, reaching Rs 160 crore for the quarter ended June 30, 2025. Indian Overseas Bank The bank announced a 10-basis-point reduction in its Marginal Cost of Funds-Based Lending Rate (MCLR) across all loan tenures. Biocon Biocon Biologics, a subsidiary of Biocon, received US FDA approval for KIRSTY (Insulin Aspart-xjhz), 100 units/mL, the first interchangeable biosimilar to NovoLog (Insulin Aspart). Kotak Mahindra Bank Phani Shankar has resigned as President and Chief Credit Officer (Senior Management Personnel) of the bank, effective July 21. Disclaimer:Disclaimer: The views and investment tips by experts in this report are their own and not those of the website or its management. Users are advised to check with certified experts before taking any investment decisions. view comments First Published: July 16, 2025, 08:32 IST Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
Mint
16-07-2025
- Business
- Mint
Stocks to watch: Tech Mahindra, HDFC Life, Dixon Tech, Bajaj Finserv among shares in focus today
Shares of Tech Mahindra, ITC Hotels, Angel One will be in focus as companies will declare Q1 results. The company posted a 14.4% year-on-year increase in net profit for the first quarter of FY26, with the profit rising to ₹ 547 crore from ₹ 478 crore in the same period last year. HDB Financial Services posted a slight drop in net profit for the first quarter of FY26, with its profit after tax standing at ₹ 568 crore — a 2% decrease from ₹ 582 crore recorded in the corresponding quarter of the previous year. Dixon Technologies has signed a binding term sheet to acquire a 51% ownership stake in Kunshan Q Tech Microelectronics Zydus Life has received final approval from the USFDA for its Celecoxib Capsules, which are used to relieve pain and inflammation associated with various conditions, including arthritis. The Insurance Regulatory and Development Authority of India (IRDAI) has given the green light for the transfer of 26% equity stake held by Allianz SE in its two insurance joint ventures—Bajaj Allianz General Insurance and Bajaj Allianz Life Insurance—to Bajaj Finserv, Bajaj Holdings & Investment (a promoter), and Jamnalal Sons (a promoter group entity). The local search engine posted a 13% year-on-year rise in net profit, reaching ₹ 160 crore for the quarter ended June 30, 2025. The bank declared a 10-basis-point cut in its Marginal Cost of Funds-Based Lending Rate (MCLR) for all loan durations. Biocon Biologics, a subsidiary of Biocon, has received approval from the US FDA for KIRSTY (Insulin Aspart-xjhz), 100 units/mL, marking it as the first and only interchangeable biosimilar to NovoLog (Insulin Aspart). Phani Shankar has stepped down from his role as President and Chief Credit Officer (Senior Management Personnel) of the bank. His resignation will take effect on July 21. Disclaimer: This story is for educational purposes only. The views and recommendations above are those of individual analysts or broking companies, not Mint. We advise investors to check with certified experts before making any investment decisions.
