Alteogen Files International Patent for Formulation Technology Enabling Development of High-Dose Eylea Biosimilar

On January 2, Alteogen, a bio-platform company, announced that it has filed an international patent (PCT) for its formulation technology that can support the development of high-dose Eylea (an ophthalmic disease treatment) biosimilars. This patent application is a strategic move to protect the formulation technology designed to ensure stable administration under various concentration conditions, based on the company’s experience in developing the Eylea biosimilar ‘Eyluxvi®’, which has already received approval in Europe.

In the global ophthalmic therapeutics market, the ability to reduce the burden of repeated injections and improve treatment convenience is emerging as a key factor in product selection. Due to the chronic nature of these diseases, patients are required to receive regular eye injections for several years, driving rapid growth in demand for treatment options that can extend dosing intervals.

Amid this trend, Roche’s Vabysmo, which was first approved as a long-acting therapy in 2022, has established itself as a major treatment option in the market, recording annual sales of approximately 4 billion dollars (about 5.788 trillion won) in 2024. Eylea HD, which has an extended dosing interval compared to existing products, also reported quarterly sales of about 430 million dollars (about 622.2 billion won) as of the third quarter of last year. According to market research firm GlobalData, Eylea HD’s global sales are projected to reach approximately 5.5 billion dollars (about 7.959 trillion won) by 2030.

The formulation technology recently filed by Alteogen is designed to ensure the stability and clinical safety of biopharmaceuticals across a wide range of concentrations. Through this, the company aims not only to enhance the competitiveness of its already approved biosimilar products but also to open up possibilities for developing subsequent ophthalmic treatments, including high-concentration formulations.

A company official stated, “This international patent application is the result of systematizing a formulation that considers the development of high-concentration pharmaceuticals, based on our experience with Eyluxvi. We plan to continuously strengthen our technological foundation to meet both patient convenience and treatment efficiency, which are required in the global ophthalmic therapeutics market.”

Alteogen plans to build a competitive portfolio in the global market by leveraging its platform capabilities and open innovation in various biopharmaceutical fields, including ophthalmic treatments.