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[by Kang, In Hyo] The biotech platform company Alteogen announced on September 17 that it has received marketing approval from the European Commission (EC) for Eyluxvi (development code: ALT-L9), a biosimilar of Eylea, co-developed with Alteogen Biologics.
Eyluxvi marks 카지노 바카라's second biosimilar approved, following the Herceptin biosimilar. The final approval was granted approximately two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in July.
Eylea (aflibercept) is a widely prescribed treatment for ophthalmic conditions, including wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). In 2024, the treatment recorded global annual sales of KRW 13 trillion (USD 9.5 billion), solidifying its status as a blockbuster drug.
With this marketing approval, Eyluxvi may now be prescribed for all indications approved for Eylea in Europe, including wet age-related macular degeneration (wAMD), macular edema secondary to branch or central retinal vein occlusion (BRVO/CRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).
"Eyluxvi is the first biosimilar to secure approval after being developed through our in-house research and subsequently advanced to global clinical development in collaboration with our subsidiary, 카지노 바카라 Biologics. This achievement has expanded our expertise not only in research and development (R&D) but also in the regulatory and approval process in Europe," said Park Soon-jae, CEO of 카지노 바카라. "We will continue to work toward delivering accessible products for patients suffering from life-threatening ophthalmic conditions such as macular degeneration," he added.
This EC approval was supported by data from a Phase 3 clinical trial conducted by 카지노 바카라 Biologics, a subsidiary of 카지노 바카라, across 12 countries, including those in Europe, as well as Korea, and Japan, between June 2022 and February 2024. The study enrolled 431 wAMD patients to assess the efficacy and safety of ALT-L9 in comparison with Eylea. The results confirmed therapeutic equivalence and a comparable safety profile to Eylea.