Latest news with #BioconBiologics
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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
25-05-2025
- Health
- Business Upturn
Biocon Biologics receives UK MHRA approval for YESINTEK, Biosimilar Ustekinumab
By Aman Shukla Published on May 25, 2025, 14:12 IST Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd., has announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for YESINTEK®, a biosimilar of Ustekinumab. YESINTEK® is approved for use in adults and children aged 6 years and older with moderate to severe plaque psoriasis. It is also indicated for adults with active psoriatic arthritis and moderately to severely active Crohn's disease. The approval follows clinical trials that demonstrated comparable safety and efficacy between YESINTEK® and the reference biologic product. This outcome supports the use of YESINTEK® as a treatment option aligned with current therapeutic standards. The MHRA authorisation enables the marketing of YESINTEK® in the United Kingdom. In parallel, Biocon Biologics also recently received marketing authorisation for Ustekinumab from the European Commission (EC), which allows its commercialisation across all European Union (EU) member states and countries in the European Economic Area (EEA). Biocon Biologics continues its efforts to expand access to biosimilar medicines in regulated markets through strategic approvals and product launches. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
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Business Standard
22-05-2025
- Business
- Business Standard
Biocon Biologics gets six-month extension of insulin supply in Malaysia
Biocon arm Biocon Biologics Limited (BBL) said in a statement that the Malaysian Ministry of Health has extended the insulin supply contract with the company. 'Biocon Biologics is pleased to inform that the Government of Malaysia has agreed to extend the current contract period of 36 months under the existing insulin supply agreement with its subsidiary in Malaysia, Biocon Sdn. Bhd., and Duopharma Marketing Sdn. Bhd. (DMktg), for an additional six (6) months, effective from 29 April 2025 until 28 October 2025,' said a company spokesperson. Biocon Biologics further stated that it has been the Ministry of Health's partner of choice for insulin supply in Malaysia for nearly a decade. Its recombinant human insulin products are manufactured at a state-of-the-art facility in Johor and distributed via commercial partner DMktg. The current supply contract runs through April 2025. The amendment to the contract will be formalised through a supplementary agreement between the Ministry of Health (MoH), Duopharma Marketing (DMktg), and Biocon. Biocon Biologics said it remains committed to providing affordable access to life-saving insulins for people with diabetes in Malaysia and globally. The company has been supplying insulin products to Malaysia for over a decade. Additionally, it operates an integrated insulin manufacturing facility in Johor, in southern Malaysia. Biocon Biologics received US Food and Drug Administration (FDA) approval for this facility earlier this year, in January. Let me know if you'd like a version tailored for social media, a press note, or infographic format.
Business Standard
21-05-2025
- Business
- Business Standard
Biocon Biologics and Yoshindo Inc. launch Ustekinumab Biosimilar in Japan
Biocon Biologics, subsidiary of Biocon, announced today that its commercial partner in Japan, Yoshindo Inc., has launched Ustekinumab BS Subcutaneous Injection [YD], a biosimilar to the reference product Stelara (ustekinumab). The biosimilar ustekinumab, developed and manufactured by Biocon Biologics, is commercialized and marketed in Japan by Yoshindo Inc. Ustekinumab, a monoclonal antibody, is approved for the treatment of psoriasis vulgaris and psoriatic arthritis (PsA). In April 2024, the Company entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize Ustekinumab in Japan upon regulatory approval. Biocon Biologics' biosimilar Ustekinumab BS Subcutaneous Injection [YD] was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in December 2024. Biocon Biologics has already launched Ustekinumab in the United States and Europe in February 2025 to help patients manage their chronic conditions.
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Business Standard
21-05-2025
- Business
- Business Standard
Biocon shares gain 2% as Japan partner launches Ustekinumab biosimilar
Shares of Biocon rose over 2 per cent on Wednesday after its unit Biocon Biologics' Japanese commercial partner launched Ustekinumab BS Subcutaneous Injection, which was developed and manufactured by the subsidiary. The pharmaceutical company's stock rose as much as 2.02 per cent during the day to ₹339.2 per share, the biggest intraday gain since May 13. The stock pared gains to trade 1.61 per cent higher at ₹337.8 apiece, compared to a 0.9 per cent advance in Nifty 50 as of 10:25 AM. Shares of the company were trading range-bound since the beginning of the month and have risen over 13 per cent from its recent lows of ₹299, which it hit in April. The counter has fallen 7 per cent this year, compared to a 5.3 per cent advance in the benchmark Nifty 50. Biocon has a total market capitalisation of ₹40,754.37 crore. Why are Biocon shares up? Biocon Biologics, a subsidiary of Biocon, announced that its commercial partner in Japan, Yoshindo Inc., has launched Ustekinumab BS Subcutaneous Injection. Developed and manufactured by Biocon Biologics, the biosimilar will be marketed in Japan by Yoshindo, it said in an exchange filing on Wednesday. Ustekinumab is a monoclonal antibody used to treat psoriasis vulgaris and psoriatic arthritis. In April 2024, Biocon Biologics signed a settlement and licensing agreement with Janssen (a group of Johnson & Johnson companies) to sell the biosimilar in Japan after regulatory approval. The drug received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in December 2024. Biocon Q4 results The Bengaluru-based biopharma major reported a 153 per cent year-on-year (Y-o-Y) rise in consolidated net profit to ₹344 crore for the fourth quarter of FY25, compared to ₹136 crore in Q4 FY24. The company's profit before tax (PBT) stood at ₹487 crore, up 53 per cent Y-o-Y. The Board has also approved a plan to raise up to ₹4,500 crore through various modes, including qualified institutional placement, rights issue, or other permissible routes. Biocon's total consolidated revenue for Q4 FY25 was ₹4,454 crore, up from ₹3,966 crore in Q4 FY24. Ebitda stood at ₹1,115 crore, marking a 16 per cent rise, with a maintained margin of 25 per cent. Biocon also secured 12 regulatory approvals and made several filings for biosimilars, including bUstekinumab, bDenosumab, and bAflibercept across multiple countries, aiming to expand patient access globally.
