FDA Approves First Interchangeable Biosimilars to Eylea

The US Food and Drug Administration has approved a pair of biosimilar products, aflibercept-jbvf and aflibercept-yszy, as interchangeable biosimilars to aflibercept (Eylea), making them the first interchangeable biosimilars to Eylea.

Announced by the FDA on May 20, 2024, the approval indicates both biosimilars for the treatment of neovascular age-related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy. According to the FDA, both are administered as a 2 mg (0.05 mL of 40 mg/mL) injectable solution to treat patients for the aforementioned conditions according to dosing regimens as recommended in each product’s labeling.¹

Aflibercept has been a staple in the treatment algorithms for a multitude of ophthalmic disorders, including those referenced above. The initial approval for aflibercept was for nAMD and was awarded in November 2011. The anti-VEGF agent would go on to secure indications for DME, macular edema following RVO, diabetic retinopathy, and retinopathy of prematurity for preterm infants in July 2014, October 2014, March 2015, March 2019, and February 2023, respectively.²

According to the FDA, the approvals of aflibercept-jbvf and aflibercept-yszy are based on a comprehensive review of scientific evidence demonstrating each product was highly similar to reference aflibercept, respectively, and there were no clinically meaningful differences from reference aflibercept. The FDA also pointed out multiple lots of Yesafili or Opuviz were compared to multiple lots of aflibercept across a range of different quality attributes, which confirmed similarity in structural and functional features. ¹

The FDA underlined the approval is also supported by comparative clinical data demonstrating the absence of clinically meaningful differences with aflibercept for efficacy’s safety, and immunogenicity. The FDA’s release noted the most common adverse events associated with use of the biosimilars in these trials were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.¹

References:

1. Office of the Commissioner. FDA approves first biosimilar to treat macular degeneration disease and other eye conditions. U.S. Food and Drug Administration. May 20, 2024. Accessed May 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-macular-degeneration-disease-and-other-eye-conditions.
2. Eylea (AFLIBERCEPT) FDA approval history. Drugs.com. May 20, 2024. Accessed May 20, 2024. https://www.drugs.com/history/eylea.html.