Alteogen's Strategic Positioning in the Biosimilars Market with Positive CHMP Opinion for Eyluxvi (ALT-L9)

The biosimilars market is undergoing a seismic shift, driven by patent expirations, regulatory streamlining, and the urgent demand for cost-effective therapies. Alteogen, a South Korean biopharmaceutical innovator, has emerged as a formidable player in this landscape, leveraging its robust pipeline, strategic partnerships, and global regulatory expertise. The recent positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for Eyluxvi (ALT-L9), a biosimilar to Eylea (aflibercept), marks a pivotal milestone. This approval not only validates Alteogen's technical and clinical capabilities but also positions the company to capitalize on high-growth markets in Europe and Asia.

Regulatory Breakthrough: CHMP Approval and European Market Access

On July 24, 2025, Alteogen received a positive CHMP opinion for Eyluxvi (ALT-L9), a biosimilar targeting aflibercept, a blockbuster ophthalmic drug used to treat wet age-related macular degeneration (wAMD), diabetic retinopathy, and other retinal diseases. This recommendation followed a rigorous Phase 3 trial involving 431 patients across 12 countries, including Japan, South Korea, and Europe, which demonstrated therapeutic equivalence to Eylea in efficacy, safety, and immunogenicity. The CHMP's endorsement is a critical step toward European Commission approval, expected within months, aligning with the expiration of Eylea's substance patent in 2025.

The European market is a strategic battleground for biosimilars, with the FDA's 2024 removal of switching studies as a requirement for interchangeability designations accelerating approvals. Alteogen's timing is impeccable: Eyluxvi is poised to enter a market where aflibercept generated over €5 billion in annual sales before generic competition. By securing early approval, Alteogen can capture a significant share of this high-margin segment while leveraging its established partnership with Qilu Pharmaceutical in China, where its Herceptin biosimilar (ALT-L2) is already commercialized.

Asia's Strategic Expansion: Partnerships and Intellectual Property

Alteogen's long-term growth hinges on its ability to scale in Asia, a region with aging populations and rising demand for ophthalmic and oncology therapies. In South Korea, the company has merged its subsidiaries, Alteogen Healthcare and Altos Biologics, to form Alteogen Biologics Inc., a unified entity focused on biosimilar development and commercialization. This move integrates distribution capabilities with R&D, enabling faster market penetration. The company submitted a marketing authorization application for ALT-L9 in South Korea in September 2024, supported by the same Phase 3 trial data that secured EMA approval.

Japan, another key market, remains a target for Alteogen's expansion. While no specific regulatory submissions for ALT-L9 in Japan are disclosed in 2025, the company's global trial included Japanese participants, and its IP strategy—patents secured in the U.S., EU, and Taiwan—positions it to enter the market post-patent expiration. Alteogen's history of licensing agreements, such as its partnership with Qilu for ALT-L2 in China, suggests a repeatable model for Japanese commercialization.

Pipeline Diversification and Future Growth

Beyond Eyluxvi, Alteogen's pipeline includes innovative biobetters and next-generation therapies. Its Hybrozyme™ platform, licensed to AstraZeneca for oncology drug delivery, could redefine subcutaneous administration of biologics, reducing healthcare costs and improving patient outcomes. Additionally, the company is advancing antibody-drug conjugates (ADCs) and long-acting proteins using its NexMab™ and NexP™-fusion technologies. These platforms target high-prevalence diseases in oncology and ophthalmology, sectors where biosimilars and biobetters are expected to grow at a compound annual rate of 12–15% through 2030.

Alteogen's intellectual property (IP) strategy further solidifies its competitive edge. Patents for ALT-L9's prefilled syringe formulation and culture methods in the U.S. and EU provide a first-mover advantage, while its licensing agreements with global partners ensure revenue diversification. The company's focus on formulation patents—rather than just substance patents—ensures long-term market exclusivity, even as competitors enter the aflibercept space.

Investment Considerations and Market Position

Alteogen's strategic positioning is bolstered by its dual focus on regulatory agility and IP protection. The biosimilars market is projected to reach $60 billion by 2030, with Europe and Asia accounting for 45% of growth. Alteogen's early mover status in aflibercept and its partnerships with industry leaders like AstraZeneca and Qilu Pharmaceutical position it to capture a disproportionate share of this expansion.

However, risks remain. Biosimilars face intense pricing pressures and regulatory hurdles, particularly in the U.S., where Alteogen has yet to submit an application for ALT-L9. Additionally, the success of Eyluxvi depends on reimbursement policies and physician adoption, which vary by region. Investors should monitor the European Commission's final approval timeline and the company's progress in securing Japanese and U.S. partnerships.

Conclusion: A High-Conviction Play in a High-Growth Sector

Alteogen's recent CHMP approval for Eyluxvi (ALT-L9) is not just a regulatory win—it's a testament to the company's ability to navigate complex global markets and build a sustainable biosimilars business. With a diversified pipeline, strategic partnerships, and a focus on IP-driven differentiation, Alteogen is well-positioned to outperform in a sector poised for long-term growth. For investors seeking exposure to the biosimilars boom, Alteogen offers a compelling mix of innovation, execution, and scalability.

As the company advances its European commercialization and eyes Asian markets, the question is no longer if Alteogen will succeed—but how fast it will dominate the biosimilars landscape.