A biosimilar to aflibercept (Eylea), a treatment used for wet age-related macular degeneration (AMD), is now available in the United States. Called aflibercept-jbvf (Yesafili), the drug was approved by the U.S. Food and Drug Administration (FDA) in May 2024, but a delay tied to patent litigation kept it off the U.S. market.
The availability of a new biosimilar gives eye specialists another option to consider for people with wet AMD. It also adds competition to the U.S. market, where biosimilars may help expand access or reduce costs, although coverage, substitution rules, and out-of-pocket savings can vary.
Yesafili is an anti-vascular endothelial growth factor (anti-VEGF) treatment injected into the eye. It is approved for the same uses as Eylea 2 milligrams, including wet AMD.
As a biosimilar, Yesafili is highly similar to Eylea and has no clinically meaningful differences in safety or effectiveness.
VEGF is a protein that can contribute to abnormal blood vessel growth and leakage in the eye. In wet AMD, these abnormal vessels can leak fluid or blood beneath the retina and damage central vision. By blocking VEGF, aflibercept products can slow abnormal blood vessel growth and help protect vision.
The FDA approves a biosimilar only after reviewing evidence showing that it is highly similar to the original biologic drug, known as the reference product, and that there are no clinically meaningful differences in safety or effectiveness.
For Yesafili, the FDA reviewed a variety of evidence comparing the biosimilar with Eylea. The agency ultimately determined that Yesafili met the requirements for approval as an interchangeable biosimilar.
An interchangeable designation means the FDA has determined that the biosimilar meets additional requirements beyond those needed for biosimilar approval. Depending on state laws and other factors, an interchangeable biosimilar may sometimes be substituted for its reference product without the prescribing healthcare professional changing the prescription.
What Are the Possible Side Effects? Like all treatments, Yesafili can cause side effects. The most common side effects reported with aflibercept products include:
Serious problems can happen after an eye injection, including endophthalmitis (a serious infection inside the eye), retinal detachment, and retinal vasculitis (inflammation of the blood vessels in the retina).
Eye specialists also monitor for increases in eye pressure and a potential risk of arterial thromboembolic events, such as stroke or heart attack.
On myAMDteam, people share their experiences with age-related macular degeneration, ask questions, and find support from others who understand.
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