FDA Approves First Eylea Biosimilars

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The FDA announced that it approved the first 2 biosimilars referencing Eylea (aflibercept) for the treatment of ophthalmic conditions, including neovascular age-related macular degeneration (AMD), macular edema, and diabetic retinopathy.

Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis' Opuviz (aflibercept-yszy) are vascular endothelial growth factor (VEGF) inhibitors that are administered intravitreally as a 2 mg (0.05 mL of 40 mg/mL) injectable solution for patients. Clinical data show that the side effects and adverse events associated with the biosimilars are similar to the reference product.

When treating eye conditions, anti-VEGF medicines stop the abnormal blood vessels leaking, growing and then bleeding under the retina, which can cause intense pain and vision loss for patients.

Both products were also approved with interchangeability desigations, meaning that upon launch Opuviz and Yesafili will be able to be substituted for the reference product at the pharmacy level without patients having to wait for their physicians to sign off on the switch first. The label is intended to reduce wait times for patients to receive their medications, mitigate struggles with drug shortages and supply chain issues, and makes obtaining biologics more convenient.

Yesafili was the first aflibercept biosimilar to be approved in the European Union. The European Commission granted the product marketing authorization in September 2023. It was also approved in the United Kingdom in November 2023.

"Biosimilars are crucial for making healthcare more affordable and accessible. Yesafili will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy, from a company with a long history of delivering high-quality, science-driven medicines, solely focused on the development and commercialization of biosimilars," commented Matt Erick, chief commercial officer of advanced markets at Biocon Biologics, in a statement.

When Opuviz launches, it will be marketed by Biogen in the United States as part of a 2019 commercialization agreement with Samsung Bioepis. The partnership also includes SB11 (Byooviz), a ranibizumab biosimilar.

Untreated AMD is the leading cause of irreversible blindness or vision loss in people over 60 years of age, according to Genentech, the maker of Lucentis—another anti-VEGF medication. Neovascular AMD, also known as wet AMD, accounts for 10% of AMD cases but results in 90% of legal blindness as a result of AMD.

According to Regeneron, the maker of Eylea, US net sales for original Eylea and high-dose Eylea (Eylea HD) $5.89 billion in 2023, including $166 million from Eylea HD following its August 2023 FDA approval.

However, the time frame of when these products will come to the US market remains up in the air, as Regeneron, the maker of Eylea, is engaging with several biosimilar manufacturers in patent litigation cases. In December 2023, Regeneron sued Samsung Bioepis over the development of Opuviz. Regeneron is also in legal disputes with Celltrion in the US, and received a settlement agreement from Biocon Biologics regarding its planned Canadian launch of Yesafili.

According to data from Cardinal Health, at least 8 aflibercept biosimilars are expected to enter the market in 2024, but similar to the adalimumab and ustekinumab spaces, patent lawsuits will likely result in settlements delaying most—if not all—aflibercept biosimilar launches.