Does Eylea have a biosimilar?

Yes, Eylea has two interchangeable biosimilars (Opuviz and Yesafili) and one biosimillar that is not designated as interchangeable (Ahzantive).

• In May 2024 the FDA approved two interchangeable biosimilars to Eylea (aflibercept) known as Opuviz (aflibercept-yszy) and Yesafili (aflibercept-jbvf). In July 2024, Ahzantive (aflibercept-mrbb), a biosimilar that is not interchangeable was also approved.
• Unlike Eylea, the 3 biosimilar products are not indicated for the treatment of patients with retinopathy of prematurity.

An interchangeable biosimilar is a biologic product that can be automatically substituted for the reference product (in this case, Eylea) by a pharmacist, depending upon state laws. Your pharmacist will not need to contact the doctor to get an approval.

It also means the reference biologic and the new biosimilar can be switched back and forth in a patient without a risk of changes in safety or effectiveness.

Substitutions with biosimilars are intended to help you and the healthcare system save money, increase insurance coverage and offer greater access to expensive biologic products.

FDA approval of Opuviz, Yesafili and Ahzantive was based on a comprehensive review of scientific evidence demonstrating that they are highly similar to the reference product Eylea with no clinically meaningful differences in terms of safety, purity, and potency.

What does Eylea and its biosimilars treat?

Eylea is an intravitreal injection (injected into the gel part of the eye) and is used to treat the following retinal eye diseases:

• Neovascular (wet) age-related macular degeneration (wet AMD)
• Macular edema following retinal vein occlusion (RVO)
• Diabetic macular edema (DME)
• Diabetic retinopathy (DR)
• Retinopathy of prematurity (ROP).

Opuviz, Yesafili and Ahzantive are approved to treat:

• Neovascular (wet) age-related macular degeneration (wet AMD)
• Macular edema following retinal vein occlusion (RVO)
• Diabetic macular edema (DME)
• Diabetic retinopathy (DR).

Unlike Eylea, Opuviz, Yesafili and Ahzantive are not approved to treat the indication of retinopathy of prematurity (ROP).

Are they given the same way?

Yes, Eylea, Opuviz, Yesafili and Ahzantive are given as a 2 mg (0.05 mL of 40 mg/mL) injectable ocular (eye) solution into the affected eye for approved indications.

You will receive the product by a healthcare provider in a clinic or medical office as an intravitreal injection (into the gel part in the back of your numbed eye), usually every 4 to 8 weeks. Your healthcare provider may recommend an alternate dose schedule (for example, every 12 weeks) based on your response to treatment.

Related questions

• What is the difference between Vabysmo and Eylea?
• What’s the difference between Eylea, Eylea HD, and Avastin?
• What are anti-VEGF drugs (VEGF inhibitors)?

Who makes Eylea biosimilars?

Opuviz is manufactured by Samsung Bioepis, Yesafili is made by Biocon Biologics Inc. and Ahzantive is a product from Formycon AG. These products are not biosimilars to Eylea HD.

Eylea, from Regeneron Pharmaceuticals, was first approved on November 18, 2011 and Eylea HD was approved on August 18, 2023. Eylea HD is a higher-dose and longer-acting injectable form of aflibercept that is only given once every 2 to 4 months after an initial dosing period.

Do the interchangeable biosimilars work just like Eylea?

Yes, all aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which helps to prevent abnormal blood vessels from forming within the eye and under the retina (a sensory membrane that lines the inside of the eye).

By blocking VEGF, aflibercept can help to slow down or reduce damage to the retina and protect your vision.

Do side effects differ between Eylea and its biosimilars?

The side effects between these products are similar. Warnings and precautions for Eylea, Opuviz, Yesafili and Ahzantive include:

• Endophthalmitis (an inflammation and possible infection of the inner eye)
• Retinal detachment
• Retinal vasculitis (eye / blood vessel inflammation) with or without occlusion
• Increases in intraocular pressure (pressure inside your eyes)
• Risk of arterial thromboembolic (clotting) events.

Common side effects include eye (conjunctival) bleeding, eye pain, cataracts, vitreous detachment (separation of gel-like fluid from retina in eye), vitreous floaters, and increased intraocular pressure.

These products should not be used (are contraindicated) if you have an eye infection, inflammation inside your eye, or you are allergic to aflibercept (the active ingredient) or any of the inactive ingredients in any product.

An allergy to aflibercept (known as a hypersensitivity reaction) may result in symptoms such as a rash, pruritus (itching), urticaria (hives), severe anaphylactic / anaphylactoid reactions (life-threatening allergic reaction), or severe inflammation inside your eye. Contact emergency medical care (in the US, call 911) if you suspect you are having a severe allergic reaction.

Related: Warnings, precautions and side effects with Eylea (in more detail)

This is not all the information you need to know about Eylea (aflibercept) ot its biosimilars for safe and effective use and does not take the place of your healthcare provider’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.