Alteogen Registers US Patent for 'Ailia' Biosimilar Cultivation Method

Global 12 Trillion Won 'Blockbuster' Ophthalmic Disease Treatment

[Asia Economy Reporter Lee Chun-hee] Alteogen announced on the 4th that it has officially received a patent grant decision (NOA) from the United States Patent and Trademark Office regarding the culturing method of 'ALT-L9,' a biosimilar (biopharmaceutical generic) under development for 'Eylea.' With this, the patent has been recognized in six countries, including China last month and the United States.

Eylea is an antibody treatment for wet age-related macular degeneration developed by Regeneron. It is a blockbuster drug with global sales reaching approximately $9.4 billion (about 12 trillion KRW) last year. Especially, as the elderly population increases worldwide, data analytics firm GlobalData estimates that the market size for wet age-related macular degeneration treatments in nine major countries including the United States, Germany, Japan, China, and Australia will reach $18.7 billion (about 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 Pharmaceutical (SCD411) are also developing Eylea biosimilars.

Alteogen's recent patent concerns the culturing method essential for the Eylea biosimilar to have similarity with the existing drug. Through this, the company has also secured rights related to methods for increasing productivity, a key competitive factor for biosimilars. In particular, since the patent registration was achieved in the United States, the world's largest pharmaceutical market, the competitiveness of ALT-L9 has been further enhanced.

An Alteogen official stated, "Securing differentiated intellectual property rights in the Eylea biosimilar market, where various global competitors exist, provides significant competitiveness," adding, "Following patent registrations in South Korea and Japan, the patent registration in the United States, the world's largest pharmaceutical market and a stronghold of intellectual property rights, is a major signal confirming the competitiveness of ALT-L9."

Currently, Alteogen is conducting global Phase 3 clinical trials of ALT-L9 through its subsidiary Altos Biologics. The plan is to complete clinical registrations in 12 countries by March next year and launch the product in line with the opening of the European Eylea biosimilar market by the first half of 2025. The patent for Eylea is scheduled to expire in Europe in 2025 and in the United States in 2027, respectively.

This content was produced with the assistance of AI translation services.