Celltrion has secured Health Canada nod for expanding its ophthalmology footprint.

 

Health Canada has approved Eydenzelt, a biosimilar referencing Eylea (aflibercept 2mg), in both vial and pre-filled syringe formats, for the treatment of all indications currently approved for Eylea.

 

“Today’s approval lays a solid foundation for Celltrion’s expansion into the Canadian ophthalmology market and represents a significant milestone in diversifying the company’s portfolio,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. 

 

“Building on this milestone, Celltrion will further strengthen its presence in Canada by leveraging its advanced manufacturing capabilities and R&D expertise to improve patient access to high-quality biosimilar treatments.”

 

Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data. 

 

A global, randomized, double-masked, parallel-group, multicenter Phase III trial examined Eydenzelt’s efficacy, safety, pharmacokinetics, and immunogenicity against Eylea in 348 patients with diabetic macular edema (DME) over 52 weeks. The study’s primary endpoint—the change in best corrected visual acuity at week 8 from baseline—confirmed that Eydenzelt met predefined equivalence criteria. Secondary endpoints also demonstrated comparable trends in efficacy, safety, and immunogenicity.

 

Eydenzelt marks Celltrion’s first Health Canada-approved biologic product in ophthalmology. The therapy has already received approvals from the European Commission and the U.S. Food and Drug Administration in February and October 2025, respectively.