Latest news with #Yesintek
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Business Standard
26-05-2025
- Business
- Business Standard
Biocon share rises as arm secures UK MHRA nod for plaque psoriasis drug
Biocon share price: Bengaluru-based pharmaceutical company Biocon shares rose as much as 1.14 per cent to hit an intraday high of ₹334.45 per share on Monday, May 26, 2025. At 9:36 AM, Biocon share price was trading 0.73 per cent higher at ₹333.05 per share. In comparison, BSE Sensex was trading 0.79 per cent higher at 82,363.10 level. Why did Biocon share price rise on Monday? Biocon share price rose after the company announced that Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has been granted market authorisation in the UK for Yesintek, a biosimilar of Ustekinumab, from the Medicines and Healthcare products Regulatory Agency (MHRA), UK. Yesintek is approved for the treatment of adults and children aged 6 years and older with moderate to severe plaque psoriasis, as well as adults with active psoriatic arthritis or moderately to severely active Crohn's disease. Clinical trials have shown that our Ustekinumab biosimilar delivers comparable safety and efficacy to the reference product. In Europe, the European Commission (EC) has recently granted marketing authorisation for Yesintek, enabling its commercialisation across all European Union (EU) member states and countries in the European Economic Area (EEA). Biocon Q4 results Biocon reported a 153 per cent year-on-year (Y-o-Y) jump in consolidated net profit to ₹344 crore for the fourth quarter of FY25, up from ₹136 crore in the same period last year. The company's profit before tax (PBT) rose 53 per cent Y-o-Y to ₹487 crore. Total consolidated revenue for the quarter stood at ₹4,454 crore, compared to ₹3,966 crore in Q4 FY24. Ebitda increased 16 per cent to ₹1,115 crore, with the Ebitda margin maintained at 25 per cent. The strong quarterly performance was driven by robust growth across its generics, biologics, and research services segments. Biocon's Board has also approved a proposal to raise up to ₹4,500 crore through various instruments, including qualified institutional placement (QIP), rights issue, or other permissible routes. READ MORE About Biocon Biocon is among the leading global biopharmaceutical companies committed to delivering affordable, high-quality medicines and innovative therapies for chronic and complex diseases such as diabetes, cancer, and autoimmune disorders. Operating in over 120 countries, Biocon has established a robust international presence. The company is a major player in the biosimilars segment, producing cost-effective alternatives to complex biologics like human insulin and insulin glargine.
Business Upturn
08-05-2025
- Business
- Business Upturn
Biocon Q4FY25 results: Net profit jumps 153% YoY to Rs 344 crore; revenue rises 12% to Rs 4,454 crore
By News Desk Published on May 8, 2025, 19:50 IST Biocon Limited reported a strong financial performance for the quarter and financial year ended March 31, 2025. For Q4FY25, consolidated revenue came in at Rs 4,454 crore, marking a 12% year-on-year (YoY) increase. On a like-for-like basis, the revenue grew 15% YoY after adjusting for revenues from Branded Formulations India (BFI). EBITDA rose 16% YoY to Rs 1,115 crore with an EBITDA margin of 25%. Core EBITDA, excluding R&D and other adjustments, came in at Rs 1,363 crore with a margin of 31%. The company posted a net profit of Rs 344 crore in Q4FY25, a significant 153% YoY jump. On a like-for-like basis, the net profit rose 162% YoY. Profit before tax (PBT) surged 53% YoY to Rs 487 crore. Segmental performance Generics : Revenue rose 46% YoY to Rs 1,048 crore, driven by strong contributions from Lenalidomide and Dasatinib launches in the U.S. : Revenue rose 46% YoY to Rs 1,048 crore, driven by strong contributions from Lenalidomide and Dasatinib launches in the U.S. Biosimilars : Revenue increased 4% YoY to Rs 2,463 crore. On an adjusted basis, it rose 9% YoY. : Revenue increased 4% YoY to Rs 2,463 crore. On an adjusted basis, it rose 9% YoY. Research Services (Syngene): Revenue climbed 11% YoY to Rs 1,018 crore. Full-year FY25 highlights For the full year, Biocon reported: Total revenue : Rs 16,470 crore, up 5% YoY (8% like-for-like) : Rs 16,470 crore, up 5% YoY (8% like-for-like) EBITDA : Rs 4,374 crore, up 5% YoY : Rs 4,374 crore, up 5% YoY Net profit: Rs 1,013 crore, down 1% YoY; however, like-for-like net profit increased 30% Dividend and capital plans The Board recommended a final dividend of Rs 0.50 per share. Additionally, it approved raising up to Rs 4,500 crore through various financial instruments for debt repayment and strategic investments. Strategic developments Biocon Biologics launched its fifth biosimilar, Yesintek (bUstekinumab), in the U.S. and Germany, and secured a U.S. market entry for Yesafili (bAflibercept). The company also partnered with Civica Inc. to increase access to insulins. Syngene crossed Rs 1,000 crore in quarterly revenue for the first time and acquired a biologics manufacturing facility in the U.S., expanding its CDMO capabilities. Biocon has also initiated an evaluation of a potential merger between Biocon Limited and Biocon Biologics. Sustainability Biocon and Biocon Biologics were both included in the S&P Global Sustainability Yearbook 2025, with Biocon ranked among the top 5% in the Biotechnology sector. News desk at
Business Standard
05-05-2025
- Business
- Business Standard
Biocon Biologics secures multiple market access agreements for Yesintek
Biocon Biologics (BBL), subsidiary of Biocon, today announced the Company has secured multiple market access agreements for Yesintek (ustekinumab-kfce), its biosimilar to Stelara (ustekinumab). The market access agreements from numerous plans represent over 100+ million lives in the United State. Express Scripts has added YESINTEK to the National Preferred Formulary (NPF) effective March 21, 2025. Cigna has added YESINTEK to its commercial formulary beginning on March 21, 2025. UnitedHealthcare has added YESINTEK to several formularies including commercial beginning May 1, 2025; managed Medicaid beginning March 1, 2025; and Medicare beginning June 1, 2025. CVS Health has added YESINTEK beginning July 1, 2025. And finally, Optum Rx has added YESINTEK to its Premium and Select formularies beginning July 1, 2025. YESINTEK has also been selected on several other formularies, including Navitus, Costco Health Solutions, MedImpact, Priority Health, University of Pittsburgh Medical Center (UPMC), and several other regional health plans. Additionally, YESINTEK has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems. The Company is also finalizing formulary agreements with other commercial carriers. YESINTEK is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, increasing patient access to more cost-effective treatment options for use in the treatment of common chronic autoimmune diseases. YESINTEK is available in all the same formulations currently provided by STELERA . The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial.
Time of India
05-05-2025
- Business
- Time of India
Biocon Biologics secures multiple market access agreements in US for Yesintek
New Delhi: Biocon Ltd on Monday said its arm Biocon Biologics Ltd has secured multiple market access agreements in the US for its biosimlar, Yesintek, that has been approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Yesintek (ustekinumab-kfce), is biosimilar to Stelara (ustekinumab). #Pahalgam Terrorist Attack Inside Operation Tupac: Pakistan's secret project to burn Kashmir Who is Asim Munir, the Zia-style general shaping Pakistan's faith-driven military revival 'Looking for partners, not preachers': India's strong message for EU amid LoC tensions "The market access agreements from numerous plans represent over 100 million lives in the United States," Biocon said in a regulatory filing. "Yesintek represents an important milestone for Biocon Biologics, as this is the first product we have launched in the United States as a fully integrated biosimilars company," Biocon Biologics CEO & Managing Director Shreehas Tambe said. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. He further said,"the strong adoption of Yesintek... in the US reflects their confidence in our science, supply reliability, and commercial capability. The listing of Yesintek on multiple formularies is another validation that payors in the US are committed to broaden access to affordable treatment options." Biocon Biologics said Express Scripts has added Yesintek to the National Preferred Formulary (NPF) effective March 21, 2025, while Cigna has added the biosimilar to its commercial formulary beginning on March 21, 2025. Live Events Similarly, UnitedHealthcare has added Yesintek to several formularies, including commercial beginning May 1, 2025; managed Medicaid beginning March 1, 2025; and Medicare beginning June 1, 2025. CVS Health and Optum Rx have added Yesintek to their premium and select formularies beginning July 1, 2025. The company further said Yesintek has also been selected on several other formularies, including Navitus, Costco Health Solutions, MedImpact, Priority Health, University of Pittsburgh Medical Center (UPMC), and several other regional health plans. Additionally, it has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems, it added. "The company is also finalising formulary agreements with other commercial carriers," it added. Yesintek is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, increasing patient access to more cost-effective treatment options for use in the treatment of common chronic autoimmune diseases, Biocon Biologics said. It is available in all the same formulations currently provided by STELERA in presentations of 45 mg/0.5 mL PFS, 90 mg/mL PFS (prefilled syringe), 45 mg/0.5 mL vial, and 130 mg/26 mL vial, it added.
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Business Standard
05-05-2025
- Business
- Business Standard
Biocon Biologics secures multiple market access coverage for Yesintek in US
Biocon Biologics, a subsidiary of Biocon, on Monday said that it has secured multiple market access agreements for Yesintek in the US, its biosimilar which resembles the properties of Stelara. Clinical trials confirmed that Yesintek demonstrated comparable pharmacokinetics, safety, efficacy, and immunogenicity. A biosimilar is a biological medicine that is highly similar to an already approved biological medicine, also known as the reference product. Pharmacy benefit management firms like US-based Express Script have added Yesintek to the National Preferred Formulary (NPF) effective March 21. US healthcare multinational Cigna has also added Yesintek to its commercial formulary beginning on March 21. Yesintek has been approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, offering patients more affordable options for managing these common chronic autoimmune conditions. It is available in the same formulations as Stelara. Additionally, Yesintek has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems. The company is also finalising formulary agreements with other commercial carriers, Biocon said in an exchange filing. The available dosages include 45 mg/0.5 mL prefilled syringe, 90 mg/mL prefilled syringe, 45 mg/0.5 mL vial, and 130 mg/26 mL vial. The US Food and Drug Administration (FDA) approved Yesintek in December 2024. 'Yesintek represents an important milestone for Biocon Biologics, as this is the first product we have launched in the United States as a fully integrated biosimilars company. The listing of Yesintek on multiple formularies is another validation that payors in the US are committed to broadening access to affordable treatment options,' said Shreehas Tambe, CEO & managing director at Biocon Biologics. Josh Salsi, head of North America at Biocon Biologics said, over 100 million Americans – representing 70 to 80 per cent of the commercial market – are now covered for Yesintek through commercial formularies.
