Biocon Biologics Ltd. (BBL), a global biosimilars company and subsidiary of Biocon Ltd. , has announced that Health Canada has granted a Notice of Compliance (NOC) for YESAFILI™ (aflibercept) on June 26, 2025. The biosimilar to EYLEA® (aflibercept) will be available in both vial and prefilled syringe presentations (2 mg/0.05 mL), with the Canadian market launch slated for July 4, 2025.
This approval marks a significant milestone as YESAFILI becomes the first biosimilar to EYLEA approved in Canada, expanding treatment options for patients with sight-threatening retinal conditions.
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 following central retinal vein occlusion (CRVO)
Visual impairment due to macular edema following branch retinal vein occlusion (BRVO)
Diabetic macular edema (DME)
Myopic choroidal neovascularization (myopic CNV)
The regulatory approval is supported by a robust body of analytical, nonclinical, and clinical evidence demonstrating high similarity to reference product EYLEA, with no clinically meaningful differences in terms of quality, safety, or efficacy.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, commented:
“The approval of YESAFILI as the first EYLEA biosimilar in Canada is a proud achievement for Biocon Biologics. This launch—our tenth biosimilar to reach the global market—highlights our scientific expertise and strong commercialization capabilities. We remain committed to expanding global access to high-quality, affordable biologics.”
Ramy Ayad, Head of Canada at Biocon Biologics, added:
“This approval is a major step forward for Biocon Biologics in Canada. By introducing YESAFILI, we are delivering on our promise to improve access to advanced retinal therapies. Canadian patients and ophthalmologists will soon benefit from a more affordable and high-quality treatment option for a range of serious retinal conditions.”
With this launch, Biocon Biologics continues to strengthen its global biosimilars portfolio and reinforces its mission to make advanced biologic treatments more accessible worldwide.