FDA Approves Aflibercept (Eylea) Biosimilars, Yesafili and Opuviz

Earlier this week, the FDA approved aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz), the first interchangeable biosimilars for aflibercept (Eylea).^1,2 These medications are used to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Both medications are vascular endothelial growth factor (VEGF) inhibitors, administered intravitreally as a 2 mg injectable solution. Anti-VEGF medications stop abnormal blood vessels from leaking, growing, and bleeding under the retina, which leads to pain and vision loss for patients.

READ MORE: Q&A: Biosimilar Access, Pricing in the Spotlight

More than 19 million Americans are living with age-related macular degeneration. The approval of these medications offers an additional treatment option to this patient population.

“Biosimilars are crucial for making health care more affordable and accessible,” said Matt Erick, Chief Commercial Officer of Advanced Markets at Biocon Biologics. Biocon is the manufacturer of Yesafili.³

FDA approval of both Yesafili and Opuviz were based on a “comprehensive review of scientific evidence demonstrating that each product is highly similar” to reference product aflibercept. Evidence included comparisons of each product to the reference product “on an analytical level, using an extensive and robust battery of physicochemical tests and biological assays” as well as a comparative clinical study in patients.

Adverse effects and events associated with aflibercept-jbvf and aflibercept-yszy are consistent to those observed with aflibercept. The most common adverse effects include conjunctival hemorrhage, eye pain, cataracts, vitreous detachment, vitreous floaters, and increased intraocular pressure. Additional risks, contraindications, and warnings include hypersensitivity; endophthalmitis, or inflammation of the vitreous humor and surrounding tissue, retinal detachments, and retinal vasculitis with or without occlusion; an increase in intraocular pressure; and thromboembolic events.

There are at least 8 aflibercept biosimilars expected to enter the US market in 2024, but—as with adalimumab and ustekinumab—pending patent lawsuits are likely to delay these biosimilar launches.²

READ MORE: Biosimilar Resource Center

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References

1. FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions. FDA. 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. Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars. May 20, 2024. Accessed May 21, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars

3. Biocon Biologics obtains US FDA approval for biosimilar aflibercept Yesafili. News release. Biocon Biologics. May 21, 2024. Accessed May 21, 2024. https://www.prnewswire.com/news-releases/biocon-biologics-obtains-us-fda-approval-for-biosimilar-aflibercept-for-yesafili-enters-us-ophthalmology-market-302150830.html