Celltrion's FDA Approval of EYLEA Biosimilar: A Game Changer for Biosimilars in Ophthalmology

A line graph illustrating the projected growth of the ophthalmology biosimilars market from 2025 to 2034, with key milestones such as patent expirations of Eylea and Lucentis, and Celltrion's EYDENZELT approval in 2025. The graph highlights the CAGR of 9% and the market's expansion from $41.97 billion to $60 billion.

Generate a bar chart comparing the global sales of Eylea ($9.52 billion in 2024) with projected market share distribution among biosimilars like EYDENZELT, including Celltrion's estimated revenue contribution by 2025.

The approval of Celltrion's EYDENZELT, a biosimilar referencing EYLEA (aflibercept), by the U.S. Food and Drug Administration (FDA) in October 2025 marks a pivotal moment in the biosimilars sector. This regulatory milestone not only underscores the growing acceptance of biosimilars in high-margin therapeutic areas like ophthalmology but also positions Celltrion as a key player in a market poised for explosive growth. For investors, the implications are profound: EYDENZELT's entry into the U.S. market could reshape competitive dynamics, drive revenue diversification, and accelerate the broader adoption of cost-effective biologics.

Market Context: A Sector on the Brink of Transformation

The ophthalmology biosimilars market is at an inflection point. According to a Towards Healthcare report, the global ophthalmology drugs market reached $45.52 billion in 2025, with biosimilars expected to grow at a compound annual growth rate (CAGR) of 5.33% through 2034. This expansion is fueled by the expiration of patents for blockbuster biologics such as Eylea and Lucentis, which together generated over $15 billion in annual sales before biosimilars entered the fray, according to a Clarivate forecast. The therapeutic equivalence of biosimilars to their reference products, coupled with their cost advantages, is creating a paradigm shift in how chronic conditions like age-related macular degeneration (AMD) and diabetic macular edema (DME) are managed, according to a Precision Business Insights report.

The urgency for affordable alternatives is further amplified by the rising prevalence of ophthalmic diseases. With the global geriatric population expanding and healthcare systems under pressure to reduce expenditures, biosimilars are increasingly viewed as a solution to sustainably scale treatment access, as noted in a GlobeNewswire release. A Fortune Business Insights forecast highlights that the ophthalmology biosimilars segment alone is projected to grow at a CAGR of 14.5% between 2024 and 2031, reaching $xx billion by 2031. This trajectory positions the sector as a high-conviction investment opportunity.

Celltrion's Strategic Move: EYDENZELT as a Catalyst

Celltrion's FDA approval of EYDENZELT represents a calculated and timely entry into the U.S. ophthalmology market. The biosimilar, which demonstrated therapeutic equivalence to Eylea in a 52-week Phase III trial involving 348 patients with DME, was detailed in a BioSpace press release. It now joins a portfolio of 11 FDA-approved biologics for the company, according to a Yonhap report. This milestone is particularly significant because Eylea, the reference drug, generated $9.52 billion in global sales in 2024, with $5.97 billion in the U.S. alone, as reported by Korea Biomed. By offering a cost-effective alternative, EYDENZELT is poised to capture a meaningful share of this market, especially as healthcare providers and payers prioritize value-based care.

Celltrion's financial projections underscore the strategic importance of EYDENZELT. The company anticipates that newer products, including EYDENZELT, will account for over 60% of its 2025 revenue, with a target of achieving 5 trillion won ($3.6 billion) in annual sales, according to a KED Global report. This aligns with broader industry trends: the global biosimilars market is forecasted to reach $60 billion by 2034, driven by innovations like EYDENZELT, according to Clarivate. For investors, the approval validates Celltrion's ability to navigate complex regulatory pathways and commercialize high-margin products in competitive markets.

Competitive Positioning and Long-Term Growth

Celltrion's entry into the U.S. ophthalmology market also strengthens its competitive positioning against industry giants like Sandoz, Amgen, and Samsung Bioepis, as noted in a SWOT analysis. While these firms dominate the biosimilars landscape, Celltrion's focus on ophthalmology-a niche yet high-growth segment-differentiates its strategy. The company's European approval of EYDENZELT in February 2025 was announced in a Celltrion press release, further demonstrating its global scalability, a critical factor in an industry where cross-border commercialization is key to maximizing returns.

Moreover, Celltrion's pipeline reinforces its long-term growth potential. The company plans to commercialize 22 biosimilars by 2030, including candidates for autoimmune and oncology indications, as covered in a Korea Biomed article. This diversification reduces reliance on any single product or market, mitigating risks associated with patent cliffs or regulatory delays. For investors, the approval of EYDENZELT is not an isolated event but a harbinger of Celltrion's broader ambition to become a global biosimilars leader.

Investment Implications: Balancing Opportunity and Risk

The approval of EYDENZELT presents both opportunities and risks for investors. On the upside, the biosimilar's entry into the U.S. market could drive immediate revenue growth and enhance Celltrion's margins, given the high pricing power of ophthalmology drugs. Additionally, the company's strategic alignment with market trends-such as the shift toward value-based care and the need for affordable chronic disease management-positions it to benefit from secular growth.

However, challenges remain. The biosimilars sector is highly competitive, with pricing pressures and market share battles intensifying as more players enter the space. Celltrion will need to demonstrate rapid market adoption of EYDENZELT and maintain its innovation edge to sustain growth. Regulatory uncertainties, such as potential delays in approvals for its pipeline candidates, also pose risks.

Conclusion: A Regulatory Milestone with Sector-Wide Impact

Celltrion's FDA approval of EYDENZELT is more than a corporate win-it is a testament to the transformative potential of biosimilars in reshaping healthcare economics. For investors, the milestone highlights the importance of regulatory progress in unlocking value, particularly in high-growth, high-margin sectors like ophthalmology. As the biosimilars market continues to expand, companies like Celltrion that combine regulatory agility with strategic diversification will likely emerge as key beneficiaries. The question for investors is not whether biosimilars will succeed, but how quickly they will dominate-and who will lead the charge.