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Photo: Celltrion |
[Alpha Biz= Kim Jisun] Celltrion Inc.’s eyecare biosimilar, Eydenzelt (active ingredient: Aflibercept), has received contrasting court rulings in Europe, reflecting the complexities of patent litigation across different jurisdictions.
On Jan. 12, the Munich District Court in Germany ruled that Eydenzelt infringed formulation patents held by Regeneron and Bayer, following precedents set in similar biosimilar cases. A Celltrion spokesperson said the ruling applies only within Germany and emphasized that the company is actively negotiating patent agreements with the originator firms, limiting the broader European risk.
On the same day, the Brussels Court in Belgium delivered a favorable decision, finding that Eydenzelt did not infringe the original product’s formulation patent (set to expire in June 2027). The court recognized a technical differentiation: unlike the original product, which uses a phosphate buffer, Eydenzelt employs a histidine buffer. This ruling clears the way for the product’s market entry in Belgium following its recent launch in the U.K. on Jan. 8.
Eydenzelt targets Regeneron’s blockbuster Eylea, which posted global sales of $9.523 billion in 2024. Celltrion received European Commission approval in February 2024 and is expanding its footprint sequentially in line with local patent outcomes.
In North America, regulatory uncertainty has already been resolved. Celltrion has reached patent agreements with Regeneron in both the U.S. (approval expected Oct. 2025) and Canada, with a U.S. market launch planned by the end of this year.
Celltrion said it remains committed to executing country-specific strategies and collaborating with originator companies to ensure smooth global market access for Eydenzelt.
Alphabiz Reporter Kim Jisun(stockmk2020@alphabiz.co.kr)
