Latest news with #ShreehasTambe
Business Standard
2 days ago
- Business
- Business Standard
Biocon's biologics arm gets Health Canada approval for aflibercept biosimilar 'Yesafili'
Biocon said that its subsidiary Biocon Biologics has received a notice of compliance (NOC) for Yesafili (aflibercept), a biosimilar to Eylea (aflibercept) injection, in vial and prefilled syringe presentations, from Health Canada. This approval paves the way for the launch of YESAFILI in Canada, scheduled for 04 July 2025. YESAFILI is the first biosimilar to EYLEA to be approved by Health Canada. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor. It is prescribed for the treatment of several eye conditions. These include neovascular (wet) age-related macular degeneration (AMD). It also treats visual impairment caused by macular edema secondary to central retinal vein vein occlusion (CRVO). Visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) is another indication. Furthermore, it is used for diabetic macular edema (DME). It also treats myopic choroidal neovascularization (myopic CNV). The approval is based on a comprehensive package of analytical, nonclinical, and clinical data, confirming that YESAFILI is highly similar with no clinically meaningful differences to EYLEA in terms of quality, safety, and efficacy. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: The approval of YESAFILI by Health Canadathe first biosimilar to EYLEA in Canadais a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch YESAFILI, making it our 10th biosimilar to be commercialized worldwide. 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 scrip rose 0.96% to currently trade at Rs 353.90 on the BSE.
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Business Standard
2 days ago
- Business
- Business Standard
Biocon Biologics to launch Eylea biosimilar Yesafili in Canada next month
Biocon Biologics, a subsidiary of Biocon Ltd, has received approval from Health Canada for Yesafili (aflibercept), a biosimilar to Eylea, marking the first such approval for an Eylea biosimilar in the country. The authorisation, granted via a Notice of Compliance (NOC), covers both vial and prefilled syringe formats (2 mg/0.05 mL). Yesafili is set to launch in Canada on July 4. Shreehas Tambe, chief executive officer and managing director, Biocon Biologics, said: 'The approval of Yesafili by Health Canada—the first biosimilar to Eylea in Canada—is a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch Yesafili, making it our 10th biosimilar to be commercialised worldwide. This milestone reflects our science-driven innovation, global commercialisation strength and continued commitment to expanding access to high-quality, affordable biologics for patients across the globe.' Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for treating several retinal conditions that cause visual impairment. These include neovascular (wet) age-related macular degeneration (AMD), macular oedema resulting from central or branch retinal vein occlusion (CRVO and BRVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV). Furthermore, the company said the approval is based on a comprehensive package of analytical, nonclinical and clinical data, confirming that Yesafili is highly similar with no clinically meaningful differences to Eylea regarding quality, safety and efficacy. In April this year, Yesafili received approval for launch in the United States. In May 2024, the US Food and Drug Administration approved Yesafili.
Yahoo
2 days ago
- Business
- Yahoo
Biocon Biologics Receives Health Canada Approval for Yesafili™ (aflibercept); First Global Launch Scheduled for July 2025
TORONTO, Ontario, Canada and BENGALURU, Karnataka, India, June 27, 2025 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for Yesafili™ (aflibercept), a biosimilar to Eylea® (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL on June 26, 2025. This approval paves the way for the launch of YESAFILI in Canada, scheduled for July 4, 2025. YESAFILI is the first biosimilar to EYLEA to be approved by Health Canada. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) Visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) Diabetic macular edema (DME) Myopic choroidal neovascularization (myopic CNV) The approval is based on a comprehensive package of analytical, nonclinical, and clinical data, confirming that YESAFILI is highly similar with no clinically meaningful differences to EYLEA in terms of quality, safety, and efficacy. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: 'The approval of YESAFILI by Health Canada—the first biosimilar to EYLEA® in Canada—is a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch YESAFILI, making it our 10th biosimilar to be commercialized worldwide. This milestone reflects our science-driven innovation, global commercialization strength, and continued commitment to expanding access to high-quality, affordable biologics for patients across the globe.' Ramy Ayad, Head of Canada at Biocon Biologics, stated: 'This is a significant achievement for Biocon Biologics in Canada. With the approval of YESAFILI, we are delivering on our promise to improve access to advanced biologic therapies. Canadian ophthalmologists and patients will soon have a high-quality, affordable biosimilar option for serious retinal diseases.' About YESAFILI™:The approval for YESAFILI (aflibercept) was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that YESAFILI is highly similar to EYLEA. In a Phase 3 INSIGHT Study, YESAFILI was compared with EYLEA in patients with Diabetic Macular Edema. This study demonstrated that there were no clinically meaningful differences between YESAFILI and EYLEA in terms of pharmacokinetics, safety, efficacy, and immunogenicity. Indications and Usage: Treatment with YESAFILI (aflibercept) is for intravitreal injection only. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) Visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) Diabetic Macular Edema (DME) Myopic choroidal neovascularization (myopic CNV) Warnings and Precautions: YESAFILI is contraindicated in patients with ocular or periocular infection, active intraocular inflammation, and hypersensitivity to aflibercept, to any ingredient in the formulation or to any component of the container. Patients may experience temporary visual disturbances after an intravitreal injection with YESAFILI and the associated eye examinations. They should not drive or use machines until visual function has recovered sufficiently. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/ anaphylactoid reactions, or severe intraocular inflammation. Endophthalmitis, retinal detachment, retinal tear, retinal pigment epithelium tear, cataract including traumatic cataract, vitreous hemorrhage and hyphema, may occur following intravitreal injections. Retinal vasculitis and retinal occlusive vasculitis, typically in the presence of intraocular inflammation or treatment with other intravitreal agents. Increases in intraocular pressure have been observed within 60 minutes of an intravitreal injection Please refer to full Product Monograph for YESAFILI for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468. YESAFILI is a trademark of a Biocon Biologics BIOLOGICS and the Biocon Biologics Logo are trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. About Biocon Biologics Limited: Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve over 5.8 million patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its portfolio which are addressing the patients' needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. For FY24 Integrated Annual Report of Biocon Biologics click here Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. Forward-Looking Statements: BioconThis press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. For More Information: Biocon Biologics MEDIA INVESTORS Seema AhujaGlobal Head of Corporate Brand & Head of Communications – Emerging Markets +91 99723 Lance LongwellPublic Relations Lead – Advanced Markets +1 857 270 Saurabh PaliwalHead - Investor RelationsBiocon +91 95383 80801 CONTACT: Lance Longwell Biocon Biologics Ltd 857-270-4391
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.
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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.
