Latest news with #BioconBiologicsLtd
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
Business Upturn
21-05-2025
- Business
- Business Upturn
Biocon subsidiary and Yoshindo expand access to Ustekinumab Biosimilar in Japan
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd, announced that its commercial partner in Japan, Yoshindo Inc., has launched Ustekinumab BS Subcutaneous Injection [YD], a biosimilar version of the reference drug Stelara® (ustekinumab). This biosimilar ustekinumab, developed and manufactured by Biocon Biologics, is being marketed and commercialized in Japan by Yoshindo Inc. Ustekinumab is a monoclonal antibody indicated for the treatment of psoriasis vulgaris and psoriatic arthritis (PsA). The biosimilar was developed and manufactured by Biocon Biologics and received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in December 2024. This launch follows a settlement and licensing agreement signed in April 2024 between Biocon Biologics and Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, allowing commercialization of Ustekinumab in Japan after regulatory approval. Biocon Biologics had earlier launched the biosimilar Ustekinumab in the United States and Europe in February 2025, expanding its availability to help patients manage chronic inflammatory conditions. 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
Mint
12-05-2025
- Business
- Mint
Biocon to evaluate merger with subsidiary Biologics
Biocon Group's board is setting up a committee to evaluate strategic restructuring options, including a merger of its biosimilars arm Biocon Biologics Ltd with its flagship Biocon Ltd. The options would be evaluated taking into consideration matters relating to legal and tax aspects and subject to all approvals, including regulatory, board and shareholders, the company said in a release dated 8 May. The company had said in February that it would likely list its biosimilars business on the stock exchanges by March 2026. Also read: Biocon share price jumps 4% as subsidiary secures market entry for Yesafili in US '…given the market volatility that we are seeing on the IPO front, the board was of the opinion that we should look at other strategic options which also be includes evaluating a merger," Kiran Mazumdar-Shaw, chairperson, Biocon Group, told investors in an earnings call on Friday. "So at this point in time the board has constituted a committee, we will evaluate all strategic options and then get back to you in a few months with what the committee recommends to the board," she added. Biocon's board also approved raising up to ₹4,500 crore by way of issue of securities via qualified institutional placements, rights issue or other permissible routes, the company said. The funds will be used for repaying borrowings by the company or its subsidiaries, fulfilling other debt obligations, as well as investments in subsidiaries. Also read: All India Chemists and Druggists association urges members to ensure adequate stock supplies in border states Biocon Biologics acquired US drugmaker Viatris' global biosimilars business in 2022 to expand its global footprint. The company's CEO and managing director Shreehas Tambe had previously said it would consider an IPO after it completed the integration of the Viatris portfolio. 'On a full-year basis, the company has recorded a strong 15% growth in FY25 and we have successfully consolidated our business worldwide," Tambe said in the release. 'Having built a strong foundation, we are well-positioned to launch 5 new products in the next 12-18 months and expand patient access." Biocon is a global biopharmaceuticals company which has developed and commercialised novel biologics, biosimilars and complex small molecule active pharma ingredients (APIs) in India and several key global markets, as well as generic formulations in the US, Europe and emerging markets. The company is focused on complex therapies in chronic segments like diabetes, cancer and autoimmune. Also read: Donald Trump announces 59% cuts in US prescription drug prices, one day after new pharma policy Biocon Biologics' four biosimilars recorded sales of $200 million each in FY25. The company also launched its fifth biosimilar product, Yesinket (Ustekinumab), in the US in FY25.
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.
