The FDA granted approval to Biocon Biologics' drug Yesafili and Samsung Bioepis and Biogen's drug Opuviz, the agency announced May 20. The two drugs are biosimilars for Eylea, an injection made by Regeneron that is used to treat wet age-related macular degeneration and other optical conditions.
The two biosimilars are the first the FDA has approved to disrupt Eylea's hold on the market since the injection's inaugural approval in 2011. With the FDA's approval of Yesafili and Opuviz, the price tag for the treatment will also get a disruption.
Currently, paying for Eylea out of pocket can cost patients $1,958 per 0.05 milliliters.
"FDA's approvals of Yesafili and Opuviz are based on a comprehensive review of scientific evidence demonstrating that each product is highly similar to Eylea, respectively, and that they have no clinically meaningful differences from Eylea," the agency wrote.
"With this approval, we now have two ophthalmology biosimilars approved by the FDA, marking an important step towards expanding treatment options for patients suffering from retinal disorders," Byoungin Jung, vice president and lead of regulatory affairs for Samsung Bioepis told Becker's. "The approval of Opuviz underscores our continued commitment to providing valuable treatment options for people who do not have access to life-enhancing biologic medicines around the world."
Becker's also reached out to Biocon Biologics and Biogen to request comment on the new drug approvals. This story will be updated if new information is received.