What is Eylea and its generic name?
Eylea is a brand-name biologic prescription medication containing the active ingredient aflibercept. Administered as an injection into the eye, it is used to treat various retinal conditions, including neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). The manufacturer of Eylea is Regeneron Pharmaceuticals.
Biologics vs. small-molecule drugs
To understand why Eylea has biosimilars and not generics, it is crucial to recognize the difference between these types of drugs. Unlike small-molecule drugs (e.g., aspirin) that are synthesized chemically and can be copied exactly, biologics are made from living systems, such as microorganisms or animal cells. This complex manufacturing process means that a biosimilar can be 'highly similar' but not identical to its reference biologic, with natural variations expected between batches. Rigorous testing ensures these differences have no clinically meaningful impact on safety or effectiveness.
The emergence of Eylea biosimilars
Following patent expiration for the brand-name Eylea, several companies have developed and received FDA approval for biosimilar versions. These products offer alternatives that can potentially reduce healthcare costs for patients and the system. As of early 2025, several aflibercept biosimilars have gained FDA approval.
Interchangeable biosimilars
Among the approved biosimilars, some have received an 'interchangeable' designation from the FDA. This means that, based on state pharmacy laws, the interchangeable biosimilar may be substituted for the reference product (Eylea) by a pharmacist without consulting the prescribing doctor, similar to how generic drugs are substituted.
Interchangeable biosimilars currently approved by the FDA include:
- Yesafili (aflibercept-jbvf)
- Opuviz (aflibercept-yszy)
Other FDA-approved biosimilars, which do not hold the interchangeable designation at this time, include:
- Ahzantive (aflibercept-mrbb)
- Enzeevu (aflibercept-abzv)
- Pavblu (aflibercept-ayyh)
Eylea biosimilar availability and patent litigation
While several aflibercept biosimilars have received FDA approval, their market availability has been complicated by patent litigation initiated by Eylea's manufacturer, Regeneron. Legal battles involving various biotech companies, including Biocon, Samsung Bioepis, Amgen, and Celltrion, have led to delays. For example, in November 2024, Amgen launched Pavblu at-risk in the U.S. amidst ongoing litigation, while other biosimilars have faced preliminary injunctions preventing their launch. Therefore, the on-the-shelf availability of these products can vary and is subject to change based on the outcomes of these legal proceedings.
Comparison of Eylea and its biosimilars
| Feature | Brand-Name Eylea | Biosimilars (e.g., Yesafili, Opuviz) |
|---|---|---|
| Active Ingredient | Aflibercept | Aflibercept + distinguishable suffix (e.g., -jbvf, -yszy) |
| Source | Produced from living cells (biologic) | Produced from living cells (biologic) |
| Approval Pathway | Approved as a reference biologic based on comprehensive clinical data | Approved via an abbreviated pathway, demonstrating high similarity to Eylea |
| Safety & Efficacy | Extensive clinical trials confirm safety and efficacy | Rigorous FDA review confirms no clinically meaningful differences from Eylea |
| Interchangeability | Is the reference product, not interchangeable | Some have an 'interchangeable' designation, allowing for pharmacy-level substitution |
| Cost | Often a higher cost option | Typically less expensive, promoting competition |
| ROP Indication | Approved for retinopathy of prematurity | Not all biosimilars are approved for retinopathy of prematurity |
Eylea vs. Eylea HD and biosimilars
It is important to distinguish between Eylea (2mg) and Eylea HD (8mg). Eylea HD is a higher-dose, longer-acting formulation of the same active ingredient, aflibercept, approved in 2023. While biosimilars exist for the original Eylea, there are currently no biosimilars available for Eylea HD. This means that patients and doctors seeking alternatives for the higher-dose version of the drug must consider other anti-VEGF therapies until biosimilars for Eylea HD gain approval and launch.
Conclusion: Navigating Eylea alternatives
For those asking is there a generic version of Eylea, the answer is no, but a number of FDA-approved biosimilars are available or pending launch. These products contain the same active ingredient, aflibercept, and have been deemed highly similar in safety and effectiveness to the original brand-name drug. They offer a potentially more affordable alternative for treating conditions like wet AMD and DME. However, patients should be aware that market availability is complex due to legal battles, and not all biosimilars are approved for all of Eylea's indications. Patients should always consult with their ophthalmologist and pharmacist to determine the most appropriate and cost-effective treatment plan. Authoritative information on biosimilars can be found on the FDA website.
