FDA Approves Yesafili (aflibercept-jbvf), an Interchangeable Biosimilar to Eylea


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May 20, 2024 -- The U.S. Food and Drug Administration (FDA) has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept).

Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye. By blocking VEGF, aflibercept products can slow down or reduce damage to the retina and help preserve vision.

The FDA also approved Opuviz (aflibercept-yszy), an interchangeable biosimilar to Eylea (aflibercept).

Both Yesafili and Opuviz are used to treat:

  • Neovascular (wet) age-related macular degeneration
  • Macular edema following retinal vein occlusion
  • Diabetic macular edema
  • Diabetic retinopathy

Both Yesafili and Opuviz are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution to treat patients for the conditions listed above according to dosing regimens as recommended in the labeling.

Disease or Condition

Neovascular (wet) age-related macular degeneration

Neovascular (wet) age-related macular degeneration (AMD) is a condition that affects the macula, which is the central part of the retina at the back of the eye. The macular is the portion of the eye that produces the ability to see fine details clearly. In wet AMD, abnormal blood vessels grow under the macula. These vessels are fragile and tend to leak blood and fluid into the macula, causing damage. This leakage can lead to distorted or blurry vision, and in severe cases, can result in significant vision loss. Wet AMD often progresses rapidly when untreated and can cause more severe vision problems. Wet AMD is more likely to occur in older adults, over the age of 65.

Macular edema following retinal vein occlusion

Retinal vein occlusion (RVO) happens when there is a blockage to one of the veins that carry blood away from the retina which can cause complications such as increased pressure and leakage leading to swelling of the macula. Macular edema from RVO can lead to blurry or distorted vision, and if severe, it can cause vision loss. Macular edema from RVO is more likely to affect older adults, over the age of 50.

Diabetic retinopathy

Diabetic retinopathy is a condition that affects the eyes of people with diabetes. In diabetic retinopathy, high levels of blood sugar can damage the tiny blood vessels in the retina, the part of the eye that senses light. In the early stages of diabetic retinopathy, the blood vessels in the retina weaken and start to leak fluid or blood. This can cause blurry vision or dark spots. In later stages, the body tries to compensate for the damaged blood vessels by growing new ones which may bleed into the eye, causing floaters or even vision loss. In people with diabetes, risk of diabetic retinopathy increases with time.

Diabetic macular edema

Diabetic macular edema (DME) happens in people with diabetic retinopathy. The damage to the blood vessels caused by high levels of blood sugar makes the vessels leaky, allowing fluid to seep into the macula. The fluid or swelling in the macula causes blurry or distorted vision. People with high risk and uncontrolled diabetes are at risk for diabetic macular edema.

Approval Information

A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by FDA (also called the reference product). This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.

An interchangeable biosimilar is a biosimilar that has met other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.

All biological products are approved only after they meet FDA’s rigorous approval standards. This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine (i.e., reference product).

FDA’s approvals of Yesafili and Opuviz are based on a comprehensive review of scientific evidence demonstrating that each product is highly similar to Eylea, respectively, and that they have no clinically meaningful differences from Eylea. This evidence included comparisons of each product to Eylea on an analytical level using an extensive and robust battery of physicochemical tests and biological assays, and in a comparative clinical study in patients.

For the analytical comparisons, multiple lots of Yesafili or Opuviz were compared to multiple lots of Eylea across a broad range of different product quality attributes. The results of these comparisons confirmed similarity in the structural and functional features of Yesafili and Opuviz with Eylea, including those known to impact safety and efficacy. The comparative clinical data to support approval of Yesafili and Opuviz included results from studies in patients to support that there were no clinically meaningful differences from Eylea with respect to efficacy, safety, and immunogenicity. The totality of these data supported FDA approval of Yesafili and Opuviz as interchangeable biosimilars to Eylea.

Safety Information for Yesafili and Opuviz

The side effects and adverse events observed in clinical studies of Yesafili and Opuviz are consistent with those observed with Eylea. The most common (≥5%) of these side effects included conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. The vitreous humor is a clear, gel-like substance that fills the space between the lens and retina in the eye.

In addition, the risks included as contraindication or under the warnings and precautions include:

  • Hypersensitivity
  • Endophthalmitis (inflammation of the vitreous humor and surrounding tissues), retinal detachments, and retinal vasculitis with or without occlusion
  • Increase in intraocular pressure
  • Thromboembolic events (blood clots)

See full prescribing information for additional information on risks associated with Yesafili and Opuviz.

Designation

Yesafili and Opuviz are the first interchangeable biosimilars to Eylea to treat certain eye conditions.

Source: FDA

Posted: May 2024

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