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 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.”
Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions like diabetes, cancer, and autoimmune diseases.
The company’s 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.