Celltrion’s Eydenzelt gets Health Canada approval for ophthalmology market

CANADA—South Korean biopharmaceutical company Celltrion has received regulatory approval from Health Canada for its biosimilar Eydenzelt, which is equivalent to Eylea (aflibercept).

Eydenzelt will be available in both pre-filled syringe and vial formats, and it is approved for all the same uses as the original Eylea treatment.

This approval follows extensive clinical evaluation, including global Phase III trials, alongside non-clinical and analytical studies.

All the data confirmed that Eydenzelt matches Eylea in terms of safety and effectiveness.

Jungyong Shin, managing director of Celltrion Healthcare Canada, described this authorization as a significant milestone, supporting the company’s strategy to broaden its product range and enter the expanding ophthalmology market.

Previously, Eydenzelt obtained approval from the European Commission in February 2025, and in October 2025, the US Food and Drug Administration granted its approval.

In Canada, Eydenzelt joins Biocon Biologics’ Yesafili and Apotex’s Aflivu, which also received Health Canada’s clearance in mid-2025.

Since the patent protecting Eylea expired in the US in May 2024, its sales have sharply declined due to growing biosimilar competition.

Analysts at GlobalData predict this decline will persist, estimating that Eylea’s sales will fall to under half of its USD3.57 billion peak revenue in 2024 by the year 2030.

In response to these challenges, Regeneron introduced Eylea HD, a version with a higher dose and longer duration of action, aiming to sustain the franchise’s success.

The US initially approved Eylea HD in 2023 for diabetic macular oedema, wet age-related macular degeneration, and diabetic retinopathy.

Despite some regulatory delays in 2025, the FDA approved Eylea HD for treating macular oedema resulting from retinal vein occlusion, further extending its therapeutic applications within ophthalmology.

However, manufacturing problems at a Novo Nordisk-owned plant have hindered approval of a pre-filled syringe version of Eylea HD.

The FDA rejected this formulation in October 2025, although pre-filled syringes would improve administration efficiency.

Eylea HD’s broader approval could help Regeneron compete with Roche, which strengthened its position in ophthalmology after gaining FDA approval for Vabysmo (faricimab-svoa) in 2022.

Since launch, Vabysmo generated USD4.4 billion in sales during 2024.

Looking ahead, GlobalData forecasts Vabysmo’s sales to reach USD9.1 billion by 2031, surpassing Eylea HD, which is expected to earn approximately USD2.7 billion that same year