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Business Standard
7 days ago
- 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).
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Business Standard
7 days ago
- Business
- Business Standard
Should you buy Biocon shares as USFDA gives approval to diabetes drug?
Biocon share price today: Shares of Biocon witnessed a 3 per cent gain, logging an intraday high of ₹405.9 on Wednesday after the company's subsidiary firm, Biocon Biologics, received US Food and Drug Administration's (FDA) approval for its diabetes drug, Insulin Aspart, marketed as Kirsty. At 09:30 AM, Biocon shares were trading at ₹398.15, up by 1.97 per cent on the National Stock Exchange. In comparison, the Nifty50 witnessed a downtrend, trading at 25,140.05, down by 0.22 per cent or 55 points. So far this calendar year, shares of the biopharma company have experienced a decent rise of 6.8 per cent. Around 7.2 million shares have changed hands on the counter, cumulatively, on the NSE and BSE at the time of writing this report. Kirsty has been available in the European Union (EU) and Canada since 2022. With the latest FDA approval, it becomes the first and only interchangeable biosimilar to NovoLog in the US. According to IQVIA data for 2024, Insulin Aspart US sales stood at $1.9 billion. This development marks Biocon Biologics' continued expansion spree in the diabetes portfolio. About Kirsty Kirsty is a rapid-acting insulin used to manage blood sugar levels in adults and children with diabetes. The insulin will be available in a prefilled pen for individual use and a multi-dose vial for both subcutaneous and intravenous usage. '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, CEO and managing director, Biocon Biologics. "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 added. Brokerage View- WealthMills Securities On an annual basis, Biocon shares have experienced a healthy double-digit rise of over 11 per cent on the bourses. Kranthi Bathini, director of equity strategy at WealthMills Securities, has maintained a 'Hold' rating on the stock. Biocon's future revenue growth will likely come from two main sources: its portfolio of biosimilars and new molecular entity. The company is also planning to merge with its subsidiary firm, Biocon Biologics, to form business synergies. Just last month, the biopharma company raised ₹4,500 crore via a qualified institutional placement (QIP) issue.
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.
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Business Standard
16-07-2025
- Business
- Business Standard
Biocon shares jump 3% after USFDA approval for diabetes insulin drug
Biocon share price today: Shares of Biocon witnessed a 3 per cent gain, logging an intraday high of ₹405.9 on Wednesday after the company's subsidiary firm, Biocon Biologics, received US Food and Drug Administration's (FDA) approval for its diabetes drug, Insulin Aspart, marketed as Kirsty. At 09:30 AM, Biocon shares were trading at ₹398.15, up by 1.97 per cent on the National Stock Exchange. In comparison, the Nifty50 witnessed a downtrend, trading at 25,140.05, down by 0.22 per cent or 55 points. So far this calendar year, shares of the biopharma company have experienced a decent rise of 6.8 per cent. Around 7.2 million shares have changed hands on the counter, cumulatively, on the NSE and BSE at the time of writing this report. Kirsty has been available in the European Union (EU) and Canada since 2022. With the latest FDA approval, it becomes the first and only interchangeable biosimilar to NovoLog in the US. According to IQVIA data for 2024, Insulin Aspart US sales stood at $1.9 billion. This development marks Biocon Biologics' continued expansion spree in the diabetes portfolio. About Kirsty Kirsty is a rapid-acting insulin used to manage blood sugar levels in adults and children with diabetes. The insulin will be available in a prefilled pen for individual use and a multi-dose vial for both subcutaneous and intravenous usage. '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, CEO and managing director, Biocon Biologics. "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 added. Brokerage View- WealthMills Securities On an annual basis, Biocon shares have experienced a healthy double-digit rise of over 11 per cent on the bourses. Kranthi Bathini, director of equity strategy at WealthMills Securities, has maintained a 'Hold' rating on the stock. Biocon's future revenue growth will likely come from two main sources: its portfolio of biosimilars and new molecular entity. The company is also planning to merge with its subsidiary firm, Biocon Biologics, to form business synergies. Just last month, the biopharma company raised ₹4,500 crore via a qualified institutional placement (QIP) issue.
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.
