Biocon Biologics (BBL), a biosimilars company and subsidiary of Biocon, has announced that Health Canada has granted a Notice of Compliance (NOC) for YESAFILI (aflibercept), a biosimilar to EYLEA (aflibercept) injection. The approval covers vial and prefilled syringe presentations, 2 mg/0.05 mL, and was granted on 26 June 2025. The company has scheduled the product’s Canadian launch for 4 July 2025.
YESAFILI is the first biosimilar to EYLEA to be approved by Health Canada. It is a vascular endothelial growth factor (VEGF) inhibitor for intravitreal injection and is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD); visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); branch retinal vein occlusion (BRVO); diabetic macular oedema (DME); and myopic choroidal neovascularisation (myopic CNV).
The approval follows a review of analytical, nonclinical, and clinical data confirming that YESAFILI is highly similar to EYLEA, with no clinically meaningful differences in quality, safety, or efficacy. A Phase 3 INSIGHT study evaluated YESAFILI against EYLEA in patients with diabetic macular oedema, with findings showing comparable pharmacokinetics, efficacy, safety, and immunogenicity.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, 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 commercialised worldwide. This milestone reflects our science-driven innovation, global commercialisation strength, and continued commitment to expanding access to high-quality, affordable biologics for patients across the globe.”
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.”
According to the press release, YESAFILI is contraindicated in patients with ocular or periocular infection, active intraocular inflammation, or hypersensitivity to aflibercept or any component of the formulation or container. Patients may experience temporary visual disturbances following injection and associated eye examinations. They are advised not to drive or operate machinery until visual function has stabilised.
Hypersensitivity reactions may include rash, pruritus, urticaria, anaphylactic reactions, or intraocular inflammation. Risks following intravitreal injection include endophthalmitis, retinal detachment, retinal pigment epithelium tear, cataract, vitreous haemorrhage, and hyphema. Retinal vasculitis and occlusive vasculitis may also occur, particularly in the presence of inflammation or prior treatment with other intravitreal agents. Intraocular pressure increases have been observed within 60 minutes post-injection.