Biocon Biologics Receives Health Canada Approval for Yesafili™ (aflibercept); First Global Launch Scheduled for July 2025

Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has received a Notice of Compliance (NOC) from Health Canada for Yesafili™ (aflibercept), a biosimilar to Eylea® (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL. This approval allows 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, and it is indicated for the treatment of various retinal diseases. 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.