FDA Approves First Interchangeable Biosimilars to Eylea
The FDA has approved Biocon’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy) as the first interchangeable biosimilars to Eylea (aflibercept).
Yesafili and Opuviz are used to treat wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy. Both Yesafili and Opuviz are administered intravitreally as a 2 mg (0.05 mL of 40 mg/mL) injectable solution.
While Regeneron warned earlier this year that biosimilar competition to Eylea might enter the market soon after the product’s exclusivity ran out on May 17, litigation will likely delay the commercial availability of any biosimilars. According to a FirstWord Pharma report[1], Regeneron has been pursuing legal action against a number of biosimilar developers, including seeking a permanent injunction against Viatris. Biocon acquired Viatris' biosimilars portfolio, including Yesafili, for $3.3 billion in 2022. Late last year, Regeneron won a favorable judgement against Viatris in relation to a formulation patent that expires in 2027, and is in the early stages of litigation with at least four other drugmakers. Citing a Morgan Stanley analysts, the report stated that Regeneron is hoping that a permanent injunction would stop the launch of Yesafili during the appeals process, while a preliminary injunction would provide certainty that the other companies could not enter the market during litigation in the district court, which they noted could take 2 to 3 years from the lawsuit filing date.
A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by FDA (the reference product). An interchangeable biosimilar is a biosimilar that has met other requirements under the law and may be substituted for the reference product without consulting the prescriber.
According to the FDA, the approvals of Yesafili and Opuviz are based on a review of scientific evidence demonstrating that each product is highly similar to Eylea, respectively, and that they have no clinically meaningful differences from Eylea [2].
"This evidence included comparisons of each product to Eylea on an analytical level using an extensive and robust battery of physicochemical tests and biological assays, and in a comparative clinical study in patients," the FDA stated in a news release. "The comparative clinical data to support approval of Yesafili and Opuviz included results from studies in patients to support that there were no clinically meaningful differences from Eylea with respect to efficacy, safety, and immunogenicity. The totality of these data supported FDA approval of Yesafili and Opuviz as interchangeable biosimilars to Eylea."
The side effects and adverse events observed in clinical studies of Yesafili and Opuviz are consistent with those observed with Eylea. The most common (≥5%) of these side effects included conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
References
1. Matthew D. First Eylea biosimilars approved in US, but litigation blurs launch optics. FirstWord Pharma. https://firstwordpharma.com/story/5858465. Accessed May 21, 2024.
2. 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. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-macular-degeneration-disease-and-other-eye-conditions. Accessed May 21, 2024.