US FDA approves two biosimilars for blockbuster eye drug Eylea

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday approved two close copies of Regeneron Pharmaceuticals' Eylea, its first-ever clearance to biosimilar versions of the blockbuster eye treatment.

The agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while also allowing interchangeability, or the drug's substitution with biosimilars without the need for a doctor's advice.

It was not immediately clear when the therapies would be launched. Regeneron has filed lawsuits against companies such as Amgen and Biocon, which are seeking to bring Eylea biosimilars to the U.S. market.Regeneron recorded U.S. sales of $5.72 billion from its regular 2 milligram (mg) dose of Eylea last year, but the drug faces pressure from rivals including Roche's Vabysmo as well as a looming biosimilar threat.

Regeneron had flagged in its 2023 annual report that it might lose market exclusivity for Eylea on May 17 this year.

To counter those challenges, Regeneron has been focusing on Eylea's higher 8 mg dose, which recorded sales of $200 million in the first quarter.

Biocon Biologics is a unit of Indian drugmaker Biocon, while Samsung Bioepis is owned by Samsung Biologics.

Regeneron, Samsung Bioepis, Biocon and Biogen did not immediately respond to Reuters' requests for comment.

(Reporting by Leroy Leo and Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar and Anil D'Silva)