Latest news with #YESAFILI
Business Standard
12 hours 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.
Business Upturn
a day ago
- Business
- Business Upturn
Biocon subsidiary gets Health Canada nod for YESAFILI
By Aman Shukla Published on June 27, 2025, 09:19 IST Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has received a Notice of Compliance from Health Canada for YESAFILI™ (aflibercept), marking a significant milestone in the company's global biosimilars journey. The regulatory approval, granted on June 26, 2025, makes YESAFILI the first biosimilar to EYLEA® (aflibercept) to be approved in Canada. The product will be available in both vial and prefilled syringe forms (2 mg/0.05 mL), with its commercial launch set for July 4, 2025. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor designed to treat several serious eye conditions. These include neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and visual impairment due to macular edema caused by retinal vein occlusion (CRVO and BRVO), as well as myopic choroidal neovascularization (myopic CNV). The approval is backed by a robust data package encompassing analytical, nonclinical, and clinical studies. Health Canada concluded that YESAFILI matches EYLEA in quality, safety, and effectiveness, with no clinically meaningful differences. This milestone not only reinforces Biocon Biologics' capabilities in developing high-quality biosimilars but also enhances patient access to affordable treatment options in Canada. Ahmedabad Plane Crash 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
