Celltrion announced on Monday that its ophthalmic drug, Eydenzelt (active ingredient: Aflibercept), is securing sequential distribution channels in major global markets through strategic patent responses.
In the U.S., the world’s largest pharmaceutical market, Celltrion obtained approval for Eydenzelt in early October last year and finalized a patent agreement with the original manufacturer, Regeneron, later that month. This agreement confirms Eydenzelt’s U.S. launch by year-end, eliminating costs and uncertainties associated with patent disputes.
Earlier in 2024, the company also completed a patent agreement in Canada, laying the groundwork for securing market share in North America through strategic negotiations with the original manufacturer.
In Europe, Celltrion received approval for Eydenzelt from the European Commission (EC) in February last year and is progressively expanding its launch across major European countries, including the UK. The company is implementing differentiated strategies based on the varying patent litigation landscapes in different European countries.
A significant development occurred on January 8 when a corporate court in Brussels, Belgium, ruled in a preliminary injunction lawsuit that Celltrion’s Eydenzelt does not infringe on the original formulation patent, set to expire in June 2027. Analysts suggest that Eydenzelt circumvents the original’s formulation patent by using a histidine buffer instead of the phosphate buffer used in the original product.
However, on the same day, the Munich District Court in Germany ruled that Eydenzelt infringed on the original’s formulation patent. This decision likely stems from a precedent where another biotech company lost a similar patent dispute regarding an Eylea biosimilar in the same Munich court.
Notably, while previous cases resulted in comprehensive sales bans across Germany and many other European countries, Celltrion’s ruling was limited to Germany. A Celltrion spokesperson stated that it is actively pursuing patent agreements with the original manufacturer, including in Germany, and it is committed to bringing the products to market swiftly.
Celltrion is adapting its approach to each country’s specific circumstances, highlighting Eydenzelt’s unique advantages as it enters markets. When necessary, the company is also engaging in proactive patent agreements with the original manufacturer to reduce uncertainties and expand into additional markets. Moreover, Celltrion plans to leverage its established direct sales network across the U.S. and Europe to rapidly penetrate markets and boost revenue growth.
The original drug, Eylea, reported global sales of 9.523 billion USD in 2024, with 5.968 billion USD generated in the U.S. alone.
A Celltrion representative commented that with the patent agreement securing Eydenzelt’s launch in the U.S., the world’s largest market, it is also implementing strategic patent responses and market entry strategies in key European countries. It is committed to swiftly establishing a market presence through country-specific patent strategies and by capitalizing on the direct sales synergies.