Alteogen Files Patent for Aflibercept Biosimilar Prefilled Injection Formulation

[Asia Economy Reporter Hyungsoo Park] Alteogen, which is developing the Eylea biosimilar (ALT-L9), a treatment for macular degeneration, announced on the 16th that it has filed a patent for the pre-filled injection formulation of the Eylea biosimilar finished product.

Recently, the macular degeneration treatment market has been shifting from vial formulations to pre-filled formulations. Alteogen has additionally filed a patent for the pre-filled injection formulation of the Eylea biosimilar under development to respond to this market transition and expand market value.

Eylea injections are pharmaceuticals that must be administered directly into the ocular lens in a small amount of only 0.05mL to prevent excessive intraocular pressure elevation. Unlike conventional biopharmaceuticals, it was relatively difficult to develop a small volume filling and post-filling sterilization method. Generally, glass pre-filled syringes are used, and an overfilling method is adopted where about 70% of the filled volume is removed before administration.

Alteogen decided to use plastic pre-filled syringes to enhance convenience and cost-effectiveness for patients and healthcare professionals and to demonstrate the superiority of its unique formulation and drug stability. They developed a new formulation method for the Eylea biosimilar product that combines a filling method allowing small volume filling of only the necessary amount and an optimal post-sterilization method.

Eylea is a treatment for wet macular degeneration, one of the major age-related blindness diseases along with cataracts and glaucoma.

An Alteogen official explained, “We have secured a patent for the formulation technology independently developed for the Eylea biosimilar product, which is undergoing global Phase 3 clinical trials at our subsidiary Altos Biologics.”

He added, “Through production processes, we have established a foundation for rapid launch in the global market,” emphasizing, “The patent for the pre-filled injection formulation of the Eylea biosimilar finished product is to respond to market transition and expand market value.”

Alteogen completed the first clinical Phase 1 trial of the Eylea biosimilar for the first time in Korea. It has registered patents for production technology essential for producing the materials necessary for Eylea biosimilar development in Korea, Japan, Australia, Russia, and other countries.