Biocon Biologics to launch Eylea biosimilar Yesafili in Canada next month

Yesafili is the first Eylea biosimilar approved in Canada and Biocon Biologics' 10th commercialised biosimilar, with launch scheduled for July 4 across the country

Biocon Biologics, a subsidiary of Biocon Ltd, has received approval from Health Canada for Yesafili (aflibercept), a biosimilar to Eylea, marking the first such approval for an Eylea biosimilar in the country. The authorisation, granted via a Notice of Compliance (NOC), covers both vial and prefilled syringe formats (2 mg/0.05 mL). Yesafili is set to launch in Canada on July 4.

 

Shreehas Tambe, chief executive officer and managing director, 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.” 

 

Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for treating several retinal conditions that cause visual impairment. These include neovascular (wet) age-related macular degeneration (AMD), macular oedema resulting from central or branch retinal vein occlusion (CRVO and BRVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).

 

Furthermore, the company said 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 regarding quality, safety and efficacy.

 

In April this year, Yesafili received approval for launch in the United States. In May 2024, the US Food and Drug Administration approved Yesafili.