Altos Biologics Seeks Approval for Aflibercept Biosimilar

On July 1, 2024, Alteogen Inc. (KOSDAQ: 196170) based in Daejeon, South Korea, announced that its subsidiary, Altos Biologics Inc., has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for their aflibercept biosimilar ALT-L9. Alteogen developed this biosimilar, which shows promise for treating wet Age-related Macular Degeneration (AMD).

The Phase 3 clinical trial for ALT-L9 began in 2022 after receiving initial approval and involved more than 400 participants across 12 countries. The trial aimed to compare the efficacy, safety, and immunogenicity of ALT-L9 with Eylea® for treating wet AMD. Conducted in Europe, South Korea, and Japan, the study focused on changes in Best-Corrected Visual Acuity (BCVA) over an eight-week period as its primary endpoint. The results indicated that ALT-L9 was therapeutically equivalent to Eylea®, leading to the submission of the MAA.

Altos Biologics anticipates gaining approval from the EMA by 2025, coinciding with the expiration of the substance patent. The company plans to engage in discussions with potential distributors globally to establish Licensing Agreements.

Dr. Soon Jae Park, the Chief Executive Officer of Alteogen, highlighted the importance of the MAA submission for ALT-L9, stating that it marks a significant milestone in their journey to commercialize proprietary products and gain international clinical experience. He expressed that this event is pivotal for Alteogen's growth as a global pharmaceutical entity.

Dr. Hyi Jeong Ji, Chief Executive Officer of Altos Biologics, mentioned that following the European MAA, there are plans to seek product approvals in other key markets, including Korea. Altos Biologics also intends to utilize the knowledge gained from the ALT-L9 trials to develop a new multi-specific fusion protein therapeutic. This therapeutic will integrate Tie2 regulators alongside anti-VEGF mechanisms, similar to Eylea®, aiming to stabilize blood vessels. The initiative positions the company to be at the forefront of developing top-tier treatments for the expanding market driven by aging populations and associated ocular conditions.

Alteogen Inc. is a biopharmaceutical company from South Korea that focuses on creating and commercializing innovative biologics, including Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Their product lineup includes long-acting therapeutic proteins and next-generation ADCs, developed using their proprietary NexP™-fusion and NexMab™ platform technologies. Additionally, they have engineered a unique recombinant human hyaluronidase enzyme leveraging Hybrozyme™ technology, which allows for the subcutaneous administration of drugs typically given via IV infusion. Founded in 2008, Alteogen is listed on KOSDAQ under the code 196170.KQ.