Celltrion's EYDENZELT FDA Approval: A Game-Changer for Ophthalmology Biosimilar Competition

Celltrion's recent U.S. FDA approval of EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron's EYLEA® (aflibercept), marks a pivotal moment in the ophthalmology biosimilar landscape. Approved on October 9, 2025, for neovascular age-related macular degeneration (wAMD), diabetic macular edema (DME), and other retinal conditions, EYDENZELT expands Celltrion's U.S. biologics portfolio to 11 products and positions the company to challenge EYLEA's dominance in a $13 billion market, according to an Asiae report. This approval, backed by Celltrion's Phase III results demonstrating therapeutic equivalence in efficacy and safety, underscores Celltrion's strategic push to capitalize on the rapid adoption of biosimilars in ophthalmology-a sector where biosimilars have achieved an average 81% market share within five years of launch, according to AJMC.

EYLEA's Dominance and the Biosimilar Challenge

EYLEA, the reference product, generated $9.52 billion in global sales in 2024, including $5.97 billion in the U.S., according to Asiae. Its market leadership stems from dosing flexibility (every six to eight weeks) and a robust safety profile, which have made it the preferred anti-VEGF therapy for wAMD and DME. However, the entry of biosimilars has begun to erode its share. For instance, Samsung Bioepis' OPUVIZ and BYOOVIZ (biosimilars to EYLEA and Lucentis, respectively) have already captured 30–40% cost savings for payers, with market shares rising to 36–40% for EYLEA biosimilars in Q1 2025, per AJMC. Despite this, pricing dynamics remain uneven. Amgen's Pavblu, another EYLEA biosimilar, launched in 2024 with only a 10% discount, offering minimal savings and limiting its ability to displace EYLEA, according to an AscellaHealth analysis.

EYDENZELT's entry could disrupt this status quo. Unlike Pavblu, Celltrion has emphasized a competitive pricing strategy, leveraging its global approvals in South Korea, the EU, and Australia to optimize manufacturing and supply chains, as shown in Celltrion's Phase III report. While exact pricing for EYDENZELT in the U.S. has not been disclosed, Celltrion's CEO has stated in a Franetic report that its biosimilars are often exempt from new U.S. tariffs and regulatory pricing pressures, suggesting a potential for deeper discounts than previous entrants. This aligns with broader trends: ophthalmology biosimilars have historically achieved 53% cost reductions after five years of competition, per AscellaHealth, and EYDENZELT's approval could accelerate this trajectory.

Strategic Implications for Market Competition

The ophthalmology biosimilar market is uniquely positioned for rapid growth due to the high unmet need for affordable anti-VEGF therapies. With nearly 20 million Americans affected by conditions like wAMD and DME, according to Asiae, payers and providers are increasingly receptive to cost-effective alternatives. EYDENZELT's approval adds to a growing list of competitors, including five FDA-approved EYLEA biosimilars as of 2024 (AscellaHealth). This intensifying competition is likely to drive further price erosion, particularly as Medicare drug price negotiations under the Inflation Reduction Act gain momentum.

However, challenges remain. EYLEA's entrenched position-supported by real-world evidence of long-term efficacy and physician familiarity-means biosimilars must overcome inertia in prescribing habits. Celltrion's strategy to address this includes emphasizing clinical equivalence data from its Phase III trial, which showed no significant differences in best-corrected visual acuity or retinal thickness compared to EYLEA (Celltrion's Phase III results). Additionally, the company's dual formulations (injection and prefilled syringe) aim to streamline administration and improve patient compliance, according to Asiae.

Investment Outlook

For investors, EYDENZELT represents a high-conviction opportunity in a sector poised for structural change. Celltrion's global approvals and U.S. market entry align with a broader industry shift toward biosimilars, which are projected to save the U.S. healthcare system $50 billion annually by 2030, per AJMC. While near-term pricing pressures may limit margins for biosimilar manufacturers, the long-term outlook is favorable: increased competition is likely to drive down costs for patients and payers, fostering broader adoption of anti-VEGF therapies.

Critically, Celltrion's success will hinge on its ability to secure favorable reimbursement terms and differentiate EYDENZELT through value-based contracting. If the company can replicate the pricing strategies of leading biosimilar players-such as Samsung Bioepis, which achieved 57% market share for ranibizumab biosimilars in Q1 2025, according to AJMC-it could emerge as a key player in the ophthalmology biosimilar space.

Conclusion

Celltrion's FDA approval of EYDENZELT is more than a regulatory milestone; it is a strategic catalyst for reshaping the ophthalmology biosimilar market. By combining robust clinical data, competitive pricing, and a global commercial footprint, Celltrion is well-positioned to challenge EYLEA's dominance and drive cost savings in a high-growth therapeutic area. For investors, this represents a compelling case study in how biosimilars can disrupt entrenched biologics markets-and why the race for market share in ophthalmology is far from over.