Samsung Bioepis Co. secured European Commission approval for Opuviz, its biosimilar version of Regeneron Pharmaceuticals Inc.’s blockbuster eye medication Eylea.
The approval marks Samsung Bioepis’s ninth biosimilar authorization in Europe and strengthens its position in the ophthalmology market. The treatment targets wet age-related macular degeneration, a leading cause of vision loss in older adults.
The original drug, Eylea, generates annual global sales of approximately 12 trillion won ($9.2 billion), highlighting the market opportunity for the South Korean drugmaker. This authorization follows U.S. approval in May and Korean approval in February, where the drug is marketed as Apilivu through Samil Pharmaceutical.
Samsung Bioepis received a positive recommendation from the European Medicines Agency’s human medicines committee in September. Opuviz represents the company’s second ophthalmology biosimilar after Byooviz, a copycat version of Lucentis.
The approval expands treatment options for European patients with macular degeneration, a condition requiring ongoing therapy to prevent potential blindness.
The company’s executive cited plans to continue expanding its biopharmaceutical portfolio, though specific launch timing for Opuviz in Europe wasn’t disclosed.
