Biosimilar Expansion in Ophthalmology: Celltrion's EYDENZELT® as a Strategic Catalyst for Market Share and Margin Growth

The biosimilars market has emerged as a transformative force in modern healthcare, with ophthalmology representing a particularly dynamic sector. Celltrion's recent U.S. FDA approval of EYDENZELT® (aflibercept-boav), a biosimilar referencing EYLEA® (aflibercept), underscores this trend and positions the company to capitalize on a high-growth therapeutic area. With EYDENZELT now approved for neovascular (wet) age-related macular degeneration (wAMD), diabetic macular edema (DME), and other retinal conditions, Celltrion has secured a strategic foothold in a market dominated by high-cost biologics.

Mechanism and Clinical Validation: A Foundation for Competitive Parity

EYDENZELT operates as a vascular endothelial growth factor (VEGF) inhibitor, blocking both VEGF-A and placental growth factor (PlGF) to combat ocular angiogenesis, according to a Celltrion press release. Its approval was underpinned by a robust phase III trial involving 348 patients with DME, which demonstrated sustained therapeutic equivalence to EYLEA over 52 weeks, as shown in the phase III trial data. The study showed progressive improvements in best-corrected visual acuity (BCVA) from baseline to week 16, with stable outcomes maintained through week 52. Notably, no significant differences were observed in secondary endpoints, including safety profiles, as reported by Ophthalmology Times. This clinical rigor not only validates EYDENZELT's efficacy but also aligns it with the high standards required for biosimilars in ophthalmology, where patient outcomes are closely tied to treatment consistency.

Strategic Positioning in a High-Stakes Market

EYLEA, the reference biologic, has long been a blockbuster in ophthalmology, generating over $5 billion annually in global sales. By offering a cost-effective alternative with equivalent therapeutic outcomes, EYDENZELT threatens to disrupt this market. Celltrion's biosimilar has already secured approvals in the European Union (February 2025) and Australia, with the U.S. FDA clearance in October 2025, the press release noted, marking its entry into the world's largest pharmaceutical market. This dual-regional approval strategy allows Celltrion to leverage cross-market learnings and accelerate adoption, particularly in the U.S., where biosimilars accounted for 12% of total prescriptions in 2024, according to a Mordor Intelligence report.

The competitive landscape is further tilted in Celltrion's favor by the broader trend of biosimilar adoption. The Mordor Intelligence report also noted that the global biosimilars market was valued at $41.97 billion in 2025 and is projected to grow at a 18.32% CAGR through 2030, driven by patent expirations of blockbuster biologics and rising demand for chronic disease treatments. In ophthalmology, where conditions like DME and wAMD require long-term, frequent dosing, the cost savings from biosimilars could be particularly impactful. For instance, EYDENZELT's entry may reduce treatment costs by 30–40% compared to EYLEA, a margin that could translate into rapid market share gains for Celltrion, the press release suggested.

Margin Expansion and Long-Term Growth Levers

Celltrion's biosimilar pipeline has historically emphasized cost efficiency, and EYDENZELT is no exception. The company's vertically integrated manufacturing model, which includes in-house production of key raw materials, enables tighter cost controls and higher gross margins compared to traditional biologics, as highlighted in Celltrion investor reports. With EYDENZELT now approved in two major markets, Celltrion can scale production to meet demand while maintaining profitability. Additionally, the biosimilar's approval for multiple indications (wAMD, DME, diabetic retinopathy, and RVO-related macular edema) broadens its revenue potential, reducing reliance on any single therapeutic area, the press release noted.

The company's strategy also benefits from the growing acceptance of biosimilars among clinicians and payers. A 2025 EMA review noted that real-world evidence has increasingly reinforced biosimilars' safety and efficacy, reducing the need for costly switching studies, the press release observed. This trend lowers regulatory and development barriers, enabling faster market entry for subsequent biosimilars. For Celltrion, this creates a flywheel effect: EYDENZELT's success could pave the way for future biosimilars in ophthalmology and beyond, further diversifying revenue streams.

Risks and Mitigation

While the outlook is optimistic, challenges remain. EYLEA's manufacturer, Regeneron, has a history of aggressive patent litigation and may contest EYDENZELT's market access. However, Celltrion's prior experience with biosimilars (e.g., Remsima/Inflectra, a biosimilar to Humira) demonstrates its ability to navigate legal and regulatory hurdles, as outlined in Celltrion investor reports. Additionally, the company's focus on patient-centric initiatives, such as co-pay assistance programs, could mitigate payer resistance and accelerate adoption.

Conclusion: A Catalyst for Biosimilar Expansion

Celltrion's FDA approval of EYDENZELT represents more than a regulatory milestone-it is a strategic catalyst for biosimilar expansion in ophthalmology. By combining clinical equivalence, cost efficiency, and a robust commercialization strategy, the biosimilar is poised to capture significant market share while enhancing Celltrion's profitability. As the global biosimilars market accelerates, investors should view EYDENZELT as a bellwether for the sector's potential to reshape high-cost therapeutic areas.