November 28, 2025 — Celltrion’s biosimilar, Eydenzelt®, has been approved by Health Canada for treating all indications of Eylea® (aflibercept 2mg). The approval includes both vial and pre-filled syringe formats.
Jungyong Shin, Managing Director at Celltrion Healthcare Canada, stated that this approval establishes a firm base for Celltrion’s growth in the Canadian ophthalmology market. It signifies a major step in the company’s efforts to broaden its offerings.
Celltrion plans to strengthen its Canadian presence by leveraging its manufacturing capabilities and R&D expertise to improve patient access to biosimilar treatments.
The approval by Health Canada was supported by comprehensive data, including analytical, nonclinical, and clinical evidence. A Phase III clinical trial compared Eydenzelt to Eylea, assessing efficacy, safety, pharmacokinetics, and immunogenicity. The trial involved 348 patients with diabetic macular edema (DME) over 52 weeks. The primary endpoint was the change in best corrected visual acuity at week 8, with results demonstrating that Eydenzelt met the predefined equivalence criteria.
Secondary endpoints related to efficacy, safety, and immunogenicity also showed similar trends between Eydenzelt and Eylea.
Eydenzelt, Celltrion’s first Health Canada-approved biologic in ophthalmology, received approval from the European Commission in February 2025 and the U.S. Food and Drug Administration in October 2025.
Eydenzelt® is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea® (aflibercept). It has been approved for all indications approved for Eylea.
Celltrion is a biopharmaceutical company focused on researching, developing, manufacturing, and marketing innovative therapeutics. It is known for launching the world’s first monoclonal antibody biosimilar and has a portfolio that includes treatments for immunology, oncology, haematology, ophthalmology, and endocrinology.
Celltrion Healthcare Canada aims to provide innovative and affordable medications, manufactured in compliance with Health Canada regulations. With the approval of Eydenzelt®, Celltrion now has ten products across eight biosimilars approved by Health Canada, including Remdantry™/ Remsima® SC (infliximab), Yuflyma® (adalimumab), Vegzelma® (bevacizumab), SteQeyma® (ustekinumab), Omlyclo® (omalizumab), Stoboclo® / Osenvelt® (denosumab), and Avtozma™ (tocilizumab).
Contact:
Jungyong Shin, Managing Director at Celltrion Healthcare Canada
Source: Celltrion Inc.
