Regeneron’s golden goose Eylea may stave off biosimilar competition until 2024 or beyond
Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.
Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.
SVB Leerink biotech analyst Geoffrey Porges said in an investor note on Monday that although Sandoz has a strong reputation for quality biosimilars since the inception of biosimilars in the US (the first-ever FDA approval for a biosimilar went to Sandoz’s Zarxio), an approval for the Eylea biosimilar may not come until 2024 or 2025.
And by then, the market may have changed.
“We believe 2024 will be a disadvantageous time for an Eylea biosimilar to enter the market since Eylea may potentially have the high-dose formulation on the market along with competitors that should extend treatment intervals much longer than every 12 weeks,” Porges wrote.
He also said to expect market share loss from Eylea to be driven by the entrance of competitors that enable improved visual acuity.
And Regeneron’s cash cow also may be exposed to any potential congressional action to lower drug prices or spending related to Medicare Part B.
Eylea is the top-selling drug in Medicare Part B. Since 2013, the program has spent more than $11.5 billion on the drug, which typically costs over $10,000 per year.