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The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by Biogen and South Korea’s Samsung Bioepis.
Both were approved for all indications of the reference product: wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Both medicines were approved for a 2 mg dose delivered by intravitreal injection, the same dose as Eylea.
An interchangeable biosimilar product may be substituted without the intervention of the prescriber, similar to generic drugs being routinely substituted at the pharmacy counter. Critics say creating two tiers of biosimilars has caused confusion, however, and FDA officials recently have called for an end to the interchangeable designation.
Biocon acquired Yesafili (aflibercept-jbvf) in 2022 from Viatris, along with biosimilars for Avastin, Lucentis, and Humira. Yesafili was approved in the European Union and the UK in 2023.
In addition to Opuviz (aflibercept-yszy), Biogen and Samsung Bioepis also teamed up to develop Byooviz, a ranibizumab biosimilar. Byooviz was approved in the EU, UK, and US in 2021.
Regeneron’s Legal Fight Ongoing
Regeneron, the maker of Eylea, has sued Biocon and Samsung Bioepis to protect its patents. On May 17, the company won a 14-day restraining order to block the launch of any aflibercept biosimilar in the US.
Regeneron recorded US sales of $5.72 billion from the 2 mg dose of Eylea in 2023, but the drug has faced pressure from rivals such as Roche’s Vabysmo and the looming biosimilar threat.
To counter those challenges, Regeneron gained approval of Eylea HD, a higher, 8 mg dose, which recorded sales of $200 million in Q1-2024.