US FDA issues approval for two aflibercept biosimilars

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The agency approved Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis, Biogen) as biosimilars to Eylea (Regeneron Pharmaceuticals).

Image credit: AdobeStock/Grandbrothers

(Image credit: AdobeStock/Grandbrothers)

The Food and Drug Administration (FDA) announced its approval of 2 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 3 products are anti-vascular endothelial growth factor (VEGF) agents, administered intravitreally for neovascular age-related macular degeneration (nAMD). 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 edema following retinal vein occlusion, diabetic macular edema, and/or 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 authorization from the European Commission in January of this year.3 Biocon Biologics Limited received marketing authorization approval in the UK for aflibercept-jbvf in November 2023.

References:
  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
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