Biocon Biologics gets Health Canada nod for biosimilar Yesafili

New Delhi, Jun 27 (PTI) Biocon Ltd on Friday said its arm Biocon Biologics has been granted a notice of compliance by Health Canada for its biosimilar Yesafili injection used to treat various ailments of the eye.

"Health Canada has granted a Notice of Compliance (NOC) for Yesafili(aflibercept), a biosimilar to Eylea injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL on June 26, 2025," a regulatory filing by Biocon said.

This approval paves the way for the launch of Yesafili in Canada, scheduled for July 4, 2025, it said, adding Yesafili is the first biosimilar to Eylea to be approved by Health Canada.

Yesafili is indicated for treatment of various eye ailments, including neovascular (wet) age-related macular degeneration , visual impairment due to macular edema secondary to central retinal vein occlusion, visual impairment due to macular edema secondary to branch retinal vein occlusion, diabetic macular edema (DME) and myopic choroidal neovascularisation, the company added.

"...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 commercialization strength, and continued commitment to expanding access to high-quality, affordable biologics for patients across the globe," Biocon Biologics CEO & MD Shreehas Tambe said.

The approval by Health Canada 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, the company said. PTI RKL ANU ANU