Updated: FDA Approves First Interchangeable Biosimilars to Eylea

FDA has approved two biosimilars that are interchangeable with Eylea (aflibercept). Biocon Biologic’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) are approved to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

wAMD occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. An estimated 1.4 million Americans have wAMD.

Diabetic retinopathy is characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. Diabetic macular edema occurs as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the United States, about 1.5 million adults are diagnosed with diabetic macular edema, while about 6 million people have diabetic retinopathy.

Aflibercept works 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.

Both Yesafili and Opuviz are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution.

Biocon officials told Formulary Watch that pricing of Yesafili will be available when it launches, but there is no word yet on when that will be. Company officials said in a news release that the approval of Yesafili marks Biocon's entry into the ophthalmology market.

Matt Erick

"Biosimilars are crucial for making healthcare more affordable and accessible, Matt Erick, chief commercial officer of Advanced Markets, Biocon Biologics, said in the news release.

This approval marks the second ophthalmology biosimilar approval for Samsung Bioepis. The company's Byooviz (ranibizumab-nuna), a biosimilar to Genentech’s Lucentis (ranibizumab) launched in July 2022. It is indicated to treat patients with several eye diseases and conditions, including neovascular age-related macular degeneration. Byooviz launched at a list price of $1,130 per single use vial, which was 40% lower than the list price of Lucentis.

related: Biogen/Samsung Bioepis Launch the Biosimilar Byooviz

Samsung Bioepis' partner Biogen will market Opuviz in the United States, but no information is available yet on pricing or when Opuviz will be available.

A high dose Eylea was approved in August 2023, with a list price of $2,625 per single-use vial, according to a Regeneron statement issued last year. For the full year 2023, Regeneron reported total sales for Eylea HD and Eylea $5.89 billion.

FDA officials said in a news release that the approvals of Yesafili and Opuviz are based on evidence demonstrating that each product is highly similar to Eylea. This includes analytical tests and biological assays, as well as a comparative clinical study in patients. “The totality of these data supported FDA approval of Yesafili and Opuviz as interchangeable biosimilars to Eylea,” officials said.

Developed by Regeneron and Bayer, Eylea also treats preterm infants with retinopathy of prematurity (ROP), a leading cause of childhood blindness worldwide. Eylea is also approved in a higher dose: 8 mg to treat patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Eylea HD is administered every four weeks for the first three months across all indications, followed by every eight to 16 weeks in wAMD and DME and every eight to 12 weeks for diabetic retinopathy.

This story was updated to include additional information from Samsung Bioepis and Biocon.