Celltrion Inc. moved closer to expanding its European footprint after regulators recommended approval of four biosimilar drugs, potentially adding 135 trillion won ($94 billion) in addressable market opportunities.
The European Medicines Agency’s key committee backed the South Korean company’s generic versions of blockbuster treatments, including Roche Holding AG’s Actemra and Regeneron Pharmaceuticals Inc.’s Eylea. The recommendations typically lead to formal approval by the European Commission.
The new medicines would help Celltrion diversify beyond its core autoimmune disease portfolio into eye disorders and bone cancer treatments. Its Eylea copycat, Eydenzelt, has already launched in South Korea, while bone disease treatments Stoboclo and Osenvelt secured domestic regulatory clearance in November.
Celltrion aims to expand its product lineup to 22 biosimilars by 2030, up from the 11 expected by 2025. The company is targeting treatments whose original versions generated significant revenue – Eylea’s global sales reached about 12 trillion won in 2023, while Actemra brought in approximately 4 trillion won.
The Incheon-based drugmaker’s expansion marks rising competition in Europe’s biosimilar market as patents expire on established medicines.
