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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.
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YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of:
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- 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)
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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.
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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.”
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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.”
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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.
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Indications and Usage:
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Treatment with YESAFILI (aflibercept) is for intravitreal injection only.
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YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:
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- 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)
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