FDA Approves First Biosimilars to Eylea

The FDA approved aflibercept-jbvf (Yesafili; Biocon Biologics) and aflibercept-yszy (Opuviz; Biogen, Samsung Bioepis), the first interchangeable biosimilars to aflibercept (Eylea; Regeneron). Aflibercept inhibits vascular endothelia growth factor, preventing abnormal blood vessel growth in the eye, thus slowing down or reducing damage to the retina to help preserve vision.¹

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Yesafili and Opuviz can treat neovascular age-related muscular degeneration, macular edema after retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Both drugs are administered intravitreally as a 2 mg injectable solution for patients.¹

The approval was based on a comprehensive review of scientific evidence that demonstrated each product was highly similar to the reference product and had no clinically meaningful differences to Eylea. The date included compare each product to the reference product on an analytical level and in comparative clinical studies, according to a press release.¹

For the analytical comparison, multiple lots of each product were compared across a broad range of product qualities, and confirmed the similarity for structural and functional features, including safety and efficacy. There were no clinical meaningful differences found between either product to Eylea in efficacy, safety, and immunogenicity. This data supports the approval as interchangeable with Eylea.¹

According to the FDA, the adverse events observed in clinical studies for both drugs were consistent with the safety profile with Eylea, with the most common being conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. Further, contraindication include hypersensitivity, endophthalmitis, increase in intraocular pressure, and thromboembolic events.¹

According to the 2024 Biosimilar Report: Insights on a Pivotal year of Evolution and Expansion, retina biosimilars are expected to have a big year in 2024.²

In an interview with Pharmacy Times, Fran Gregory, PharmD, MBA, vice president of Emerging Therapies at Cardinal Health, said, ““Our research was really focused on the area of retina specialists, with a lot of buzz and a lot of opportunity for cost savings in the retina space with Eylea, Avastin, and Lucentis biosimilars. We've really focused a lot of research on that area to gain insight on a new therapeutic area that doesn't have as much experience as oncology providers do and see kind of into their world and what they are considering as far as biosimilar opportunities and challenges.”²

The biosimilar report highlights the retina space, including a survey that showcased the familiarity and comfort with biosimilars, cost savings and reimbursement practices, educational programs, and the pipeline of biosimilars that are in late-stage development.²

The authors of the report found that 61% of retina specialists believe biosimilars are improving care for patients, and 75% believe biosimilars improve health system sustainability. As for familiarity, approximately 80% are either extremely or very familiar for biosimilars, however, approximately 60% have actually prescribed biosimilars for retinal indications. Furthermore, the majority of respondents said that the most important decision-making factor for considering a biosimilar is clinical data, followed by real-world data, and payer coverage, according to the study authors.²

The biosimilar report also includes analyses of the economic, competitive, legislative, and societal landscapes in the biosimilar industry.²

References

1. FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions. News release. FDA. May 20, 2024. Accessed May 20, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye?utm_medium=email&utm_source=govdelivery

2. Gallagher A. Report: 2024 Projected to Be A Big Year for Biosimilars in the Retina Space. Pharmacy Times. March 8, 2024. Accessed May 21, 2024. https://www.pharmacytimes.com/view/report-2024-projected-to-be-a-big-year-for-biosimilars-in-the-retina-space