South Korean biopharma Celltrion has obtained regulatory approval for its Eylea (aflibercept) biosimilar, Eydenzelt, from Health Canada.
The therapy will now be available in both a pre-filled syringe and a vial version. Eydenzelt is designated for use in all approved Eylea indications.
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Eydenzelt’s approval was granted based on clinical data collected in global Phase III studies, as well as non-clinical and analytical data – which all demonstrated the comparable efficacy and safety of the biosimilar to the original Eylea formulation.
According to Celltrion Healthcare Canada managing director Jungyong Shin, this approval is a positive step forward for the company, which is currently looking to diversify its portfolio, while expanding into the growing ophthalmology market.
Eydenzelt was previously given regulatory approval by the European Commission (EC) in February 2025 while the US Food and Drug Administration (FDA) greenlighted the drug in October 2025.
The therapy joins two other approved Eylea biosimilars in Canada: Biocon Biologics’ Yesafili and Apotex’s Aflivu, which got the go-ahead from Health Canada in June and July 2025, respectively.
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By GlobalDataRegeneron looks to boost Eylea revenues
Since the US expiry of Eylea’s regulatory patent in May 2024, the drug’s sales have been on a steep downward trajectory – primarily due to biosimilar competition. Analysts at GlobalData forecast that this trend will continue, with Eylea sales set to drop to less than half of the $3.57bn value observed in its 2024 sales peak by 2030.
GlobalData is the parent company of Pharmaceutical Technology.
To fend off the financial losses associated with Eylea’s recent patent cliff, Regeneron launched Eylea HD – a higher-dose, longer-acting version of its highly successful predecessor.
While Eylea HD originally gained US approval in diabetic macular oedema (DME), wet age-related macular degeneration (wAMD) and diabetic retinopathy (DR) in 2023.
Despite a review delay this year, the FDA also approved Eylea HD for macular oedema following retinal vein occlusion (RVO) this month, expanding the drug’s use cases across the field of ophthalmology.
Manufacturing shortcomings at a Novo Nordisk-owned facility are still dashing approval hopes for a pre-filled syringe version of Eylea HD. The FDA rejected this formulation of the drug in October 2025. Pre-filled syringes would further bolster the franchise with more efficient administration.
Eylea HD’s expansion to further indications could help the company keep up with Roche, which became a dominant force in the ophthalmology market after winning approval for Vabysmo (faricimab-svoa) in 2022. Since its debut, the drug has become a best-seller for the Swiss big pharma company, raking in $4.4bn in 2024 alone.
While analysts at GlobalData forecast that Eylea HD will not be able to keep up with the $9.1bn sales forecasted for Vabysmo in 2031, the drug is estimated to bring in $2.7bn for Regeneron in 2031.
