Alteogen's Novel Biosimilar EYLUXVI® Secures European Commission Approval

Alteogen's EYLUXVI®: A Breakthrough in Ophthalmic Treatments

Alteogen Inc., a South Korean biopharmaceutical company, has made a major leap with the recent approval from the European Commission (EC) for its biosimilar product EYLUXVI® (code name: ALT-L9). This marks a significant milestone as it's the second biosimilar received by the company, following the successful launch of its Herceptin® biosimilar in 2023. The now-approved EYLUXVI® is a biosimilar to Eylea® (aflibercept), a well-known and highly utilized treatment for various ophthalmic diseases, including wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

The European Commission's endorsement comes two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on it. This approval allows EYLUXVI® to be utilized throughout Europe in treating conditions such as wAMD, macular edema induced by retinal vein occlusion, DME, and myopic choroidal neovascularization.

Dr. Soon Jae Park, CEO of Alteogen, commented on this achievement, highlighting that EYLUXVI® is the first biosimilar product developed through their in-house research and extensive global clinical development in collaboration with their subsidiary, Alteogen Biologics. He further emphasized the company's commitment to enhancing patient access to effective treatment options for serious ophthalmologic disorders.

The basis of this EC approval lies in Phase 3 clinical trials conducted across 12 countries, including several in Europe, South Korea, and Japan. These trials occurred from June 2022 to February 2024, involving a comparative clinical evaluation with 431 patients suffering from wAMD. Results from this study demonstrated that EYLUXVI® exhibits both efficacy and safety profiles that are effectively equivalent to its reference drug, Eylea®. This confirmation of therapeutic equivalence reinforces trust in the biosimilar's potential impact in the clinical setting.

Alteogen’s ambitions are driven by its advanced capabilities in research and development, alongside the valuable insights gained from navigating the European regulatory landscape. The company is not only focusing on biosimilars but also innovating other biopharmaceutical products, including Antibody-Drug Conjugates (ADCs) and long-acting therapeutic proteins, fostering an advanced portfolio tailored to meet diverse health needs.

Founded in 2008, and listed on the KOSDAQ under the ticker symbol 196170, Alteogen Inc. has built a reputation for pioneering biopharmaceutical solutions. Consideration of their proprietary technologies like NexP™-fusion and NexMab™ emphasizes their dedication to innovation and market readiness.

With the EC's green light for EYLUXVI®, Alteogen is poised to make substantial contributions to the global ophthalmic treatment landscape, enhancing patient care, and expanding access to vital therapies.

Overall, this approval not only illustrates Alteogen's strategic growth trajectory but also highlights the importance of biosimilars in making essential treatments available to patients in need.