FDA approves first interchangeable biosims to Regeneron Eylea

May 21, 2024

The U.S. FDA has approved the first two interchangeable biosimilars to Regeneron's blockbuster eye disorder drug, Eylea.

The approvals were granted to Biocon Biologics' Yesafili and Samsung Bioepis and Biogen's Opuviz. The drugs, which are VEGF inhibitors, are approved as 2 mg injections into the eye to treat patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

Opuviz will be marketed by Biogen in the U.S. as part of a 2019 commercialization agreement with Samsung Bioepis, a subsidiary of South Korea's Samsung Biologics. That same agreement also included Byooviz, a biosimilar to Roche's blockbuster eye drug Lucentis, which became the first ophthalmology biosimilar approved in the U.S. in 2021.

For Biocon Biologics, a subsidiary of India's Biocon, the approval of Yesafil marks the company's expansion into the ophthalmology therapeutic area in the U.S. Biocon has run into issues with the U.S. regulator in the past, with the agency issuing three Form 483s following inspections of two manufacturing facilities in India back in 2022.

First approved in 2011 to treat patients with wet AMD, Regeneron's Eylea, jointly developed with Bayer, has been a best seller for the partners. The original formulation, along with the higher dose version approved last year, brought in net sales of $5.89 billion in 2023.