United States FDA approves two aflibercept 2 mg biosimilars

The biosimilars are suitable for treating patients with nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema and/or diabetic retinopathy. Image credit: ©Tada Images – stock.adobe.com

On Monday, the United States Food and Drug Administration (FDA) announced its approval of two biosimilars as interchangeable with aflibercept 2 mg (Eylea).¹ The agency approved aflibercept-jbvf (Yesafili, Biocon Biologics) and aflibercept-yszy (Opuviz, Samsung Bioepis, Biogen). All three products are anti-vascular endothelial growth factor (VEGF) agents, administered intravitreally for neovascular age-related macular degeneration (nAMD). In the US, aflibercept-jbvf and aflibercept-yszy are the first interchangeable biosimilars to aflibercept 2 mg.

In a news release, the FDA described the products as “interchangeable biosimilars,” suitable for treating patients with nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy. The news release went on to detail the safety profile for aflibercept-jbvf and aflibercept-yszy. “The side effects and adverse events observed in clinical studies of Yesafili and Opuviz are consistent with those observed with Eylea,” the agency wrote.¹ “The most common (≥5%) of these side effects included conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.”

Following the FDA approval of aflibercept 8 mg (EYLEA HD) in August 2023, Regeneron has placed a focus on the higher-dose product, recording $200 million in sales in the first quarter of 2024.² Aflibercept 8 mg also received EU marketing authorisation from the European Commission in January of this year.³ Biocon Biologics Limited received marketing authorisation approval for aflibercept-jbvf from the EU in September, and in the UK in November 2023.

Reference

1. FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions. US Food & Drug Administration. May 20, 2024. Accessed May 21, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye

2. US FDA approves two biosimilars for blockbuster eye drug Eylea. Reuters. May 20, 2024. Accessed May 21, 2024. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-biocon-units-biosimilar-blockbuster-eye-drug-eylea-2024-05-20/

3. Hayes H. European Commission grants EU marketing authorisation for aflibercept (Eylea) 8 mg. Ophthalmology Times Europe. January 8, 2024. Accessed May 21, 2024. https://europe.ophthalmologytimes.com/view/european-commission-grants-eu-marketing-authorisation-for-aflibercept-eylea-8-mg