The U.S. Food and Drug Administration (FDA) has officially approved Eydenzelt (aflibercept-jbvf), a new biosimilar developed by Celltrion. This medication is interchangeable with Eylea (aflibercept), a widely used treatment for several serious retinal conditions, including neovascular (Wet) Age-Related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME).
This approval marks a significant development in the ophthalmology market, introducing a more affordable treatment alternative for millions of patients in the United States. The introduction of biosimilars like Eydenzelt is expected to increase competition and potentially lower healthcare costs associated with managing these chronic, vision-threatening diseases.
Key Takeaways
- The FDA has approved Celltrion's Eydenzelt as a biosimilar to Regeneron's Eylea.
- Eydenzelt is approved for treating Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy.
- As a biosimilar, Eydenzelt offers a clinically equivalent but potentially more cost-effective alternative to Eylea.
- The approval was based on a global Phase III clinical trial involving 348 patients with DME, which confirmed its efficacy and safety.
Details of the FDA Approval
The FDA granted approval for Eydenzelt on October 10, 2025, following a thorough review of clinical data submitted by the South Korean biopharmaceutical company Celltrion. The decision confirms that Eydenzelt is highly similar to its reference product, Eylea, and that there are no clinically meaningful differences between the two in terms of safety, purity, and potency.
This approval covers all major indications for which Eylea is prescribed. Patients with wAMD, DME, and Diabetic Retinopathy (DR) are now eligible to be treated with Eydenzelt. These conditions are leading causes of vision loss, particularly among older adults and individuals with diabetes.
What are Biosimilars?
A biosimilar is a biological product that is very similar to an already approved original biologic, known as the reference product. To gain FDA approval, a biosimilar must demonstrate that it is just as safe and effective as the original drug.
Unlike generic drugs, which are identical copies of simpler, chemically synthesized medications, biologics are large, complex molecules produced in living systems. Because of this complexity, it is impossible to create an exact copy. Instead, biosimilars are engineered to be highly similar, with the same mechanism of action and clinical outcomes.
The Role of Aflibercept in Eye Care
Aflibercept, the active ingredient in both Eylea and Eydenzelt, is a vascular endothelial growth factor (VEGF) inhibitor. VEGF is a protein that stimulates the growth of abnormal, leaky blood vessels in the eye, which is a primary cause of vision damage in conditions like wAMD and DME. By blocking VEGF, aflibercept helps to reduce swelling, slow vision loss, and in some cases, improve vision.
Clinical Evidence Supporting Eydenzelt
Celltrion's application for Eydenzelt was supported by a robust data package, including results from a pivotal global Phase III clinical trial. The study was designed to compare the efficacy, safety, and immunogenicity of Eydenzelt directly against Eylea.
The trial enrolled 348 patients diagnosed with Diabetic Macular Edema. According to the study findings, patients treated with Eydenzelt showed a comparable improvement in Best Corrected Visual Acuity (BCVA) at eight weeks to those treated with Eylea. This primary endpoint demonstrated the non-inferiority of the biosimilar.
Market Impact of Eylea
Eylea, developed by Regeneron Pharmaceuticals, is a blockbuster drug with global sales exceeding $9 billion annually. The introduction of biosimilars like Eydenzelt is poised to introduce significant competition into this lucrative market.
Safety and Efficacy Confirmed
The safety profile of Eydenzelt was also found to be consistent with that of Eylea throughout the 56-week study period. There were no significant differences in adverse events or immune responses between the two treatment groups. This comprehensive data was crucial for the FDA's decision to grant approval and confirm its interchangeability.
"The approval of Eydenzelt is a milestone for patients with retinal diseases. Providing a safe, effective, and more affordable treatment option is critical to expanding access to care and managing healthcare costs," a Celltrion spokesperson stated in a press release.
Implications for Patients and the Healthcare System
The availability of Eydenzelt is expected to have a broad impact on the U.S. healthcare landscape. For patients, it introduces a new, potentially lower-cost option for managing chronic conditions that require long-term treatment. Regular injections of anti-VEGF medications can be a significant financial burden.
Increased Access and Affordability
The primary benefit of biosimilars is their potential to reduce costs. By creating competition, they can drive down prices for both the biosimilar and the original reference drug. This can lead to substantial savings for patients, insurance providers, and government healthcare programs like Medicare.
- Reduced Out-of-Pocket Costs: Patients may see lower co-pays and deductibles.
- System-Wide Savings: Insurers and federal programs could save billions of dollars, which can be reallocated to other healthcare needs.
- Expanded Treatment Access: Lower costs may enable more patients to access and adhere to their prescribed treatment regimens, improving overall public health outcomes.
Conditions Treated by Eydenzelt
Eydenzelt is approved for several retinal vascular diseases that can lead to severe vision impairment or blindness if left untreated.
- Neovascular (Wet) Age-Related Macular Degeneration (wAMD): A leading cause of vision loss in people over 50, characterized by the growth of abnormal blood vessels under the macula.
- Diabetic Macular Edema (DME): A complication of diabetes where blood vessels in the retina leak fluid into the macula, causing blurred vision.
- Diabetic Retinopathy (DR): Another diabetes complication that affects blood vessels in the retina.
The Future of Ophthalmic Biosimilars
The approval of Eydenzelt is part of a growing trend in the pharmaceutical industry. As patents for major biologic drugs expire, more companies are developing biosimilars for various therapeutic areas, including oncology, immunology, and now ophthalmology.
Several other biosimilars for Eylea are currently in development or under review by regulatory agencies worldwide. This influx of new products is expected to further intensify competition in the coming years, creating a more sustainable market for biologic therapies.
For ophthalmologists and their patients, this means more choices and greater flexibility in treatment planning. The proven efficacy and safety of biosimilars like Eydenzelt provide confidence that patient outcomes will not be compromised while achieving significant cost savings.