Alteogen Files International Patent Application for 'Eylea' Biosimilar Prefilled Syringe

[Asia Economy Reporter Chunhee Lee] Alteogen announced on the 14th that it has filed an international patent application under the Patent Cooperation Treaty (PCT) for the prefilled syringe formulation of 'ALT-L9,' a biosimilar of 'Eylea' (a biosimilar drug) currently under development. This is Alteogen's third patent related to the Eylea biosimilar, following patent applications for the formulation and composition.

The PCT international application system allows applicants to designate the countries where they wish to obtain patents by submitting a PCT international application to their national patent office. This is recognized as filing applications simultaneously in each designated country, making it easier to acquire patents among PCT member countries. Through a single application, applicants can achieve the effect of filing directly in multiple member countries.

Eylea is a blockbuster drug that generated approximately 9 trillion KRW in global sales last year. However, as patents in major global markets will expire by 2025, starting with Japan and China this year, many pharmaceutical and biotech companies, including Alteogen, are striving to develop Eylea biosimilars.

Alteogen's strategy is to secure market leadership by filing patents not only for the formulation and composition but also for the prefilled syringe formulation. Since the prefilled syringe formulation accounts for about 75% of Eylea's global sales due to its high safety, cost-effectiveness, and lower risk of infection, it is expected that the prefilled syringe formulation will completely replace the vial formulation within a few years. In particular, Alteogen emphasized that by using plastic containers instead of conventional glass syringes, it can reduce side effects caused by silicone oil.

An Alteogen representative stated, "Compared to global competitors developing Eylea biosimilars, we believe no other company has secured intellectual property rights covering the formulation, composition, and prefilled syringe," adding, "These patents will be a strong competitive advantage for success in the global Eylea market."

Currently, Alteogen is conducting global Phase 3 clinical trials of ALT-L9 in 12 countries worldwide, aiming to complete them by the end of 2023. Clinical trial applications (IND) have been submitted in all countries, and among them, five countries have obtained regulatory approval and are conducting screening for patient selection.