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)