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US FDA approves two biosimilars to blockbuster eye drug Eylea
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US FDA approves two biosimilars to blockbuster eye drug Eylea
May 20, 2024 8:21 AM

May 20 (Reuters) - The U.S. Food and Drug Administration

on Monday approved two close copies of Regeneron

Pharmaceuticals' ( REGN ) blockbuster eye drug, Eylea,

potentially hurting the company's efforts to market a higher

dose version of the treatment.

Regeneron recorded U.S. sales of $5.72 billion from its

regular 2 mg dose of Eylea last year, but the drug has come

under pressure from rivals including Roche's Vabysmo as

well as looming threats from biosimilars.

The FDA approved Biocon Biologics' biosimilar Yesafli as

well as Opuviz by Samsung Bioepis and Biogen, according

to information on the agency's website.

Biocon Biologics is a unit of Indian drugmaker Biocon

, while Samsung Bioepis is owned by Samsung Biologics

.

Regeneron, Biocon, Samsung Bioepis and Biogen did not

immediately respond to Reuters' requests for comment.

(Reporting by Leroy Leo in Bengaluru; Editing by Shilpi

Majumdar and Anil D'Silva)

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