Alteogen begins phase 3 study of Eylea biosimilar to get approval by 2025

Alteogen said on Wednesday that it completed patient recruitment for the global phase 3 clinical trials of ALT-L9, its Eylea (ingredient: aflibercerpt) biosimilar being clinically developed by its subsidiary Altos Biologics.

Eylea treats diabetic macular edema (DME) and wet age-related macular degeneration (AMD). 

ALT-L9 is the only eye treatment that has undergone phase 1 clinical trials to confirm its safety and effectiveness to evaluate pharmacokinetic properties, Alteogen said.

Additionally, the company secured competitive intellectual property rights by registering formulation patents with higher heat stability, manufacturing method patents that enable effective production, and pre-filled injection syringes (PFS) patents.

The global phase 3 clinical trial is currently underway with 431 patients in 12 countries, and the completion of patient recruitment announced this time means that the last patient has been confirmed as a suitable candidate for the clinical trial and enrolled in the clinical program. 

Registered patients go through a prescribed number of doses and follow-up observations according to the clinical program.

“Altos Biologics was able to recruit patients faster than the original plan by closely communicating with local clinical institutions and hopes to score product approval in the first half of 2025,” said an Alteogen official.

Eylea, developed by Regeneron Pharmaceuticals, is a blockbuster drug that sold about $5.8 billion in the U.S. and $9.2 billion worldwide in 2021. Thus, expectations are high for Alteogen’s biosimilar, the company said.

For global opportunities, Altos Biologics is actively discussing the out-licensing of ALT-L9 with companies holding sales capabilities and expertise in each region, to secure appropriate sales channels after phase 3 trials are successfully completed, the company added.