Altos Biologics Completes Patient Enrollment for Ailia Biosimilar Phase 3 Trial

Alteogen exterior view
[Photo by Alteogen]

[Asia Economy Reporter Chunhee Lee] Altos Biologics, a subsidiary of Alteogen, announced on the 22nd that it has completed global Phase 3 patient recruitment for 'ALT-L9,' a biosimilar (biopharmaceutical generic) of 'Eylea,' a treatment for ophthalmic diseases such as macular degeneration.

This Phase 3 clinical trial is being conducted on 431 patients across 12 countries. Completion of patient recruitment means that the last patient has been confirmed to be eligible for the clinical trial and has been enrolled in the clinical program. Enrolled patients will undergo a predetermined number of doses and follow-up observation processes according to the clinical program.

An Alteogen official stated, “Altos Biologics was able to recruit patients faster than originally planned by maintaining close communication with local clinical institutions,” adding, “We plan to submit approval materials, including the Phase 3 clinical trial results, early next year.”

Eylea is an antibody treatment developed by Regeneron for ophthalmic diseases such as wet macular degeneration. It is a blockbuster drug with global sales reaching $9.6474 billion (approximately 12.5657 trillion KRW) last year. As the elderly population increases worldwide, data analytics firm GlobalData estimates that the market size for wet macular degeneration treatments in nine major countries including the United States, Germany, Japan, China, and Australia will reach $18.7 billion (approximately 24 trillion KRW) by 2028. Besides macular degeneration, it is also used to treat diabetic macular edema and retinal vein occlusion macular edema. In South Korea, besides Alteogen, Samsung Bioepis (SB15), Celltrion (CT-P42), and Samchundang Pharm (SCD411) are also developing biosimilars of Eylea.

Altos Biologics is a subsidiary of Alteogen established in October 2020. It was founded as a company dedicated to the development and marketing of ALT-L9. Immediately after its establishment, Alteogen transferred all ALT-L9 related technologies to Altos Biologics. The structure was reorganized so that Alteogen is responsible for substance production and supply, while Altos Biologics handles development and sales.