Alteogen Registers Patent for 'Eylea' Biosimilar Fermentation Method in China

[Asia Economy Reporter Lee Chun-hee] Alteogen announced on the 21st that it has registered a patent for the fermentation method of 'ALT-L9,' a biosimilar (biopharmaceutical generic) of the macular degeneration treatment 'Eylea,' in China. This brings the total number of countries where the patent has been obtained to five, including Korea, Australia, Russia, and Japan.

Currently, Alteogen also holds formulation patents and a 'Pre-filled Syringe' formulation patent using plastic related to ALT-L9. According to the company, Alteogen is the only developer of Eylea biosimilars that has secured intellectual property rights (IP) related to these three types.

Based on this competitiveness, Alteogen plans to increase its market share in the approximately 9 trillion KRW Eylea market, starting with the expiration of the European substance patent in 2025. In Korea, besides Alteogen, Samsung Bioepis (SB15), Celltrion (CT-P42), and Samchundang Pharm (SCD411) are also developing Eylea biosimilars.

An Alteogen official explained, "This patent registration means that the uniqueness of the manufacturing method of ALT-L9 has been recognized by major national patent offices," adding, "We believe it will also help with additional patent registrations." The same patent for the fermentation method is currently under examination in Europe and the United States.

ALT-L9 is currently undergoing global Phase 3 clinical trials in 12 countries worldwide through Alteogen's subsidiary, Altos Biologics. Approvals for clinical trial protocols (IND) and clinical institutions are being obtained from regulatory agencies in each country. In the first three countries to receive approval?Japan, Bulgaria, and Latvia?patient recruitment and screening have been completed. Altos Biologics plans to complete patient recruitment by March next year.

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