Latest news with #Biocon
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.
Economic Times
2 days ago
- Business
- Economic Times
Biocon drops plan to launch weight-loss drugs in China, executive says
Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel Indian drugmaker Biocon has abandoned plans to market generic versions of Novo Nordisk 's hot-selling diabetes and weight-loss drugs in China due to local competition, a senior executive said."We decided not to do it in China, not supply or register the product in China, either finished product or the API, because there is ample capacity and players available in China," Amit Kaptain, head of Biocon's commercial active pharmaceutical ingredients (API) business, told Reuters in had said in 2024 that Biocon was aiming to launch its versions of Novo's diabetes and weight-loss drugs Ozempic and Wegovy in the world's second-biggest economy after clinical diabetes and weight-loss products would have joined at least 15 other generics or biosimilars in development by Chinese drugmakers, Reuters has reported. Biosimilars are versions of a drug that are highly similar to approved drugmakers have rushed to develop generics or biosimilars as the patent for semaglutide, a key ingredient in both Ozempic and Wegovy, ends in early 2026 in number of adults in China who are overweight is projected to reach 540 million in 2030 and those who are obese 150 million, increases of 2.8 and 7.5 times respectively from the year 2000, according to a 2020 study by Chinese public health researchers.
Time of India
2 days ago
- Business
- Time of India
Biocon drops plan to launch weight-loss drugs in China, executive says
Indian drugmaker Biocon has abandoned plans to market generic versions of Novo Nordisk 's hot-selling diabetes and weight-loss drugs in China due to local competition, a senior executive said. "We decided not to do it in China, not supply or register the product in China, either finished product or the API, because there is ample capacity and players available in China," Amit Kaptain, head of Biocon's commercial active pharmaceutical ingredients (API) business, told Reuters in Shanghai. Kaptain had said in 2024 that Biocon was aiming to launch its versions of Novo's diabetes and weight-loss drugs Ozempic and Wegovy in the world's second-biggest economy after clinical trials. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Play War Thunder now for free War Thunder Play Now Undo Biocon's diabetes and weight-loss products would have joined at least 15 other generics or biosimilars in development by Chinese drugmakers, Reuters has reported. Biosimilars are versions of a drug that are highly similar to approved medications. Chinese drugmakers have rushed to develop generics or biosimilars as the patent for semaglutide, a key ingredient in both Ozempic and Wegovy, ends in early 2026 in China. Live Events The number of adults in China who are overweight is projected to reach 540 million in 2030 and those who are obese 150 million, increases of 2.8 and 7.5 times respectively from the year 2000, according to a 2020 study by Chinese public health researchers.
Reuters
2 days ago
- Business
- Reuters
India's Biocon drops plan to launch weight-loss drugs in China, executive says
SHANGHAI, June 27 (Reuters) - Indian drugmaker Biocon ( opens new tab has abandoned plans to market generic versions of Novo Nordisk's ( opens new tab hot-selling diabetes and weight-loss drugs in China due to local competition, a senior executive said. "We decided not to do it in China, not supply or register the product in China, either finished product or the API, because there is ample capacity and players available in China," Amit Kaptain, head of Biocon's commercial active pharmaceutical ingredients (API) business, told Reuters in Shanghai. Kaptain had said in 2024 that Biocon was aiming to launch its versions of Novo's diabetes and weight-loss drugs Ozempic and Wegovy in the world's second-biggest economy after clinical trials. Biocon's diabetes and weight-loss products would have joined at least 15 other generics or biosimilars in development by Chinese drugmakers, Reuters has reported. Biosimilars are versions of a drug that are highly similar to approved medications. Chinese drugmakers have rushed to develop generics or biosimilars as the patent for semaglutide, a key ingredient in both Ozempic and Wegovy, ends in early 2026 in China. The number of adults in China who are overweight is projected to reach 540 million in 2030 and those who are obese 150 million, increases of 2.8 and 7.5 times respectively from the year 2000, according to a 2020 study by Chinese public health researchers.
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
