Does Eylea have a biosimilar?

Yes, Eylea has five biosimilars: two that are designated as interchangeable (Opuviz and Yesafili) and three that are not interchangeable (Ahzantive, Enzeevu and Pavblu).

An interchangeable biosimilar is a biologic product that can be automatically substituted for the reference product (in this case, Eylea) by your 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.

Approval overview

• 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), and in August 2024 Enzeevu (aflibercept-abzv) and Pavblu (aflibercept-ayyh), three biosimilars that are not interchangeable were also approved.
• Unlike Eylea, these biosimilar products are not indicated for the treatment of patients with retinopathy of prematurity.
• In addition, Enzeevu is only approved to treat patients with neovascular (wet) age-related macular degeneration (AMD). Unlike the other biosimilars, it is not indicated for the treatment of patients with macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

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 biosimilars are 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, Ahzantive and Pavblu 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, Ahzantive and Pavblu are not approved to treat the indication of retinopathy of prematurity (ROP).

Enzeevu is approved to treat

• Neovascular (wet) age-related macular degeneration (wet AMD).
• Iit is not indicated for the treatment of patients with macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, or retinopathy of prematurity.

Are they given the same way?

Yes, all products 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.

Who makes Eylea biosimilars?

• Opuviz is manufactured by Samsung Bioepis
• Yesafili is made by Biocon Biologics Inc.
• Ahzantive is a product from Formycon AG.
• Enzeevu is manufactured by Sandoz.
• Pavblu is made by Amgen.

Are Eylea biosimilars also biosimilars to Eylea HD?

No, the FDA-approved biosimilars for Eylea are not biosimilars to Eylea HD. 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.

Eylea was first approved on November 18, 2011 and Eylea HD was approved on August 18, 2023. Both products are manufactured by Regeneron Pharmaceuticals,

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 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) or 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.