Celltrion Accelerates Global Market Expansion for Ophthalmic Treatment Eydenzelt

Active Patent Settlement Negotiations with the Original Developer

Celltrion announced on January 12 that its ophthalmic treatment 'Eydenzelt' (ingredient: aflibercept) is sequentially securing distribution channels in major global markets through strategic patent management.

Celltrion

Celltrion first obtained product approval for Eydenzelt in the United States, the world's largest pharmaceutical market, in October last year. In the same month, the company also reached a patent settlement with the original developer, Regeneron. Through this agreement, Celltrion has confirmed the U.S. launch of Eydenzelt by the end of this year and has completely resolved both the cost burden and uncertainties associated with patent disputes. Previously, in 2024, Celltrion also finalized a patent settlement in Canada, establishing a foothold to secure market share in North America through strategic discussions with the original company.

In Europe, Celltrion received approval for Eydenzelt from the European Commission (EC) in February last year and is gradually expanding its launch to major European countries, including the United Kingdom. In particular, Celltrion is implementing differentiated market entry strategies in Europe, tailored to the varying patent litigation statuses in each country. A notable example is the ruling by the Brussels Enterprise Court in Belgium on January 8 (local time), which determined that Celltrion's Eydenzelt did not infringe on the original formulation patent in a preliminary injunction case.

On the other hand, on the same day in Germany, the Munich District Court ruled that Eydenzelt did infringe on the original formulation patent. This outcome is interpreted as being adversely affected by precedent, as another biosimilar company had previously lost both a preliminary injunction and main lawsuit regarding the Eylea biosimilar formulation patent at the same Munich District Court.

In this way, Celltrion is emphasizing the unique advantages secured by Eydenzelt and is pursuing market entry strategies tailored to each country's situation. Where necessary, the company is also actively seeking patent settlements with the original developer to resolve uncertainties. Furthermore, Celltrion plans to leverage its direct sales network established across the United States and Europe to accelerate market entry and drive revenue growth.

The global sales of Eylea, the original drug for Eydenzelt, reached $9.523 billion (approximately 13.3322 trillion won) in 2024. Of this, $5.968 billion (about 8.3552 trillion won) was generated in the United States alone.

A Celltrion representative stated, "Eydenzelt is set to launch in the United States this year following a patent settlement in the world's largest market, and we are also making strategic patent responses and market entries in major European countries. We will do our utmost to ensure rapid market penetration through strategies tailored to each country's patent situation and by maximizing the synergy of our direct sales network."