Alteogen's Aflibercept Biosimilar Eyluxvi Receives Positive Opinion from European Medicines Agency
Key Insights
Alteogen announced that its aflibercept biosimilar Eyluxvi (search) (ALT-L9) received a positive opinion from the European Medicines Agency (search)'s CHMP committee, marking a decisive step toward European approval.
The positive recommendation is based on Phase 3 clinical trial results from 431 wet age-related macular degeneration (search) patients across 12 countries, demonstrating therapeutic equivalence and safety compared to Eylea.
Eyluxvi (search) targets the blockbuster ophthalmology market, with Eylea generating annual sales of $9.5 billion for treating conditions like wet age-related macular degeneration (search) and diabetic macular edema (search).
Alteogen announced on November 28th that its aflibercept biosimilar Eyluxvi (search) has received a positive opinion from the European Medicines Agency (search)'s Committee for Medicinal Products for Human Use (CHMP), bringing the company closer to securing approval for its second biosimilar product in the lucrative ophthalmology market.
The CHMP's affirmative opinion plays a decisive role in European Commission drug approvals, with official product authorization typically decided within two to three months following the positive recommendation. This milestone positions Alteogen to compete in the market for aflibercept, a blockbuster drug that generated annual sales of $9.5 billion last year.
Clinical Trial Success Drives Regulatory Progress
The positive opinion stems from results of a Phase 3 clinical trial conducted by Alteogen's subsidiary Altos Biologics (search) from June 2022 to February 2024. The multinational study enrolled 431 patients with wet age-related macular degeneration (search) across 12 countries, including Europe, South Korea, and Japan.
The trial evaluated changes in Best-Corrected Visual Acuity over an 8-week period as the primary endpoint, comparing ALT-L9's efficacy, safety, and immunogenicity against the reference product Eylea. The study demonstrated therapeutic equivalence between ALT-L9 and Eylea, meeting the regulatory requirements for biosimilar approval.
Targeting High-Value Ophthalmology Market
Eylea (aflibercept) serves as a widely used treatment for serious ophthalmic conditions including wet age-related macular degeneration (search) and diabetic macular edema (search). The drug's substantial market presence makes it an attractive target for biosimilar development.
"Alteogen is differentiated from competing products because it has several patents such as formulation and manufacturing for Eylea biosimilars," said Alteogen CEO Park Soon-jae. "It will provide new accessible treatment options to patients suffering from fatal eye diseases such as wet age-related macular degeneration (search)."
Building on Biosimilar Portfolio
This achievement marks Alteogen's second biosimilar success following ALT-L2, a Herceptin (trastuzumab) biosimilar commercialized in China. The company transferred ALT-L2's development and commercialization rights to Qilu Pharmaceutical (search) in 2017, with Qilu completing development and securing approval from Chinese licensing authorities last year. Alteogen continues to receive periodic royalties from certain sectors of net sales.
Altos Biologics (search) expects to receive EMA approval by 2025, aligned with the substance patent expiration, and plans to negotiate license agreements with potential distributors worldwide. Dr. Park emphasized that the Marketing Authorization Application submission represents "significant milestones in commercializing our proprietary products and gaining global clinical experience" and "a crucial moment for Alteogen's growth as a global pharmaceutical company."