Alteogen Subsidiary Applies for European Approval of 'Ailia Biosimilar'

Altos Biologics announced on the 1st that it has completed the global Phase 3 clinical trial of ALT-L9, a biosimilar candidate for the ophthalmic disease treatment drug Eylea, developed by its parent company Alteogen and currently undergoing clinical trials by Altos Biologics, and has submitted the marketing authorization application to the European Medicines Agency (EMA).

Alteogen Headquarters and Research Center Exterior View

The Phase 3 clinical trial of ALT-L9 was conducted as an equivalence study comparing efficacy, safety, and immunogenicity with the original drug in over 400 subjects across 12 countries including Europe, South Korea, and Japan. Regarding the primary endpoint, the change in best corrected visual acuity (BCVA) over 8 weeks compared to baseline, ALT-L9 demonstrated therapeutic equivalence to Eylea.

Eylea is an ophthalmic disease treatment drug for conditions such as macular degeneration, jointly developed by Regeneron in the United States and Bayer in Germany. Macular degeneration is considered a representative cause of blindness. Blood and other fluids leaking from abnormally grown capillaries in the macula, the core of the retina, adhere to the retina and obscure vision. Aging is a major cause, so the incidence is increasing significantly amid the global aging trend. According to GlobalData, a global market research firm, the market for macular degeneration treatments in the seven major G7 countries including the United States, France, and Germany is expected to grow from $7.4 billion in 2021 to $27.5 billion (approximately 38 trillion KRW) by 2031. Macular degeneration is treated by regularly injecting drugs such as Eylea, which inhibit new blood vessel formation, directly into the eye to suppress disease progression. Eylea recorded sales of $9.36 billion (approximately 13 trillion KRW) last year.

Altos Biologics plans to obtain marketing authorization for ALT-L9 in line with the schedule to enable sales starting from the patent expiration next year. Additionally, it intends to enter licensing agreements with the companies best positioned to sell in each region.

Park Soon-jae, CEO of Alteogen, said, “The completion of ALT-L9’s clinical trial and submission of the marketing authorization application hold great significance in terms of commercializing self-developed products and developing personnel with global clinical experience,” adding, “It will be an important milestone for Alteogen’s growth into a global pharmaceutical company.” Ji Hee-jung, CEO of Altos Biologics, also stated, “Following the submission of the marketing authorization application in Europe, we plan to proceed with marketing authorization applications targeting key markets such as South Korea.”