Celltrion secures Well being Canada go-ahead for Eylea biosimilar
South Korean biopharma Celltrion has obtained regulatory approval for its Eylea (aflibercept) biosimilar, Eydenzelt, from Well being Canada.
The remedy will now be accessible in each a pre-filled syringe and a vial model. Eydenzelt is designated to be used in all accepted Eylea indications.
Uncover B2B Advertising and marketing That Performs
Mix enterprise intelligence and editorial excellence to achieve engaged professionals throughout 36 main media platforms.
Eydenzelt’s approval was granted based mostly on medical information collected in world Part III research, in addition to non-clinical and analytical information – which all demonstrated the comparable efficacy and security of the biosimilar to the unique Eylea formulation.
In line with Celltrion Healthcare Canada managing director Jungyong Shin, this approval is a constructive step ahead for the corporate, which is at the moment seeking to diversify its portfolio, whereas increasing into the rising ophthalmology market.
Eydenzelt was beforehand given regulatory approval by the European Fee (EC) in February 2025 whereas the US Meals and Drug Administration (FDA) greenlighted the drug in October 2025.
The remedy joins two different accepted Eylea biosimilars in Canada: Biocon Biologics’ Yesafili and Apotex’s Aflivu, which acquired the go-ahead from Well being Canada in June and July 2025, respectively.
Regeneron seems to be to spice up Eylea revenues
Because the US expiry of Eylea’s regulatory patent in Could 2024, the drug’s gross sales have been on a steep downward trajectory – primarily on account of biosimilar competitors. Analysts at GlobalData forecast that this pattern will proceed, with Eylea gross sales set to drop to lower than half of the $3.57bn worth noticed in its 2024 gross sales peak by 2030.
GlobalData is the guardian firm of Pharmaceutical Expertise.
To fend off the monetary losses related to Eylea’s current patent cliff, Regeneron launched Eylea HD – a higher-dose, longer-acting model of its extremely profitable predecessor.
Whereas Eylea HD initially gained US approval in diabetic macular oedema (DME), moist age-related macular degeneration (wAMD) and diabetic retinopathy (DR) in 2023.
Regardless of a overview delay this 12 months, the FDA additionally accepted Eylea HD for macular oedema following retinal vein occlusion (RVO) this month, increasing the drug’s use circumstances throughout the sector of ophthalmology.
Manufacturing shortcomings at a Novo Nordisk-owned facility are nonetheless dashing approval hopes for a pre-filled syringe model of Eylea HD. The FDA rejected this formulation of the drug in October 2025. Pre-filled syringes would additional bolster the franchise with extra environment friendly administration.
Eylea HD’s growth to additional indications may assist the corporate sustain with Roche, which grew to become a dominant pressure within the ophthalmology market after profitable approval for Vabysmo (faricimab-svoa) in 2022. Since its debut, the drug has turn into a best-seller for the Swiss huge pharma firm, raking in $4.4bn in 2024 alone.
Whereas analysts at GlobalData forecast that Eylea HD won’t be able to maintain up with the $9.1bn gross sales forecasted for Vabysmo in 2031, the drug is estimated to herald $2.7bn for Regeneron in 2031.
Join our day by day information round-up!
Give your enterprise an edge with our main trade insights.
