First Biosimilar to Treat Eye Disease Gains FDA Approval

Competition From Biosimilars Could Save Money for Patients, Providers and Payers

WASHINGTON, D.C. – The Food and Drug Administration (FDA) today approved Byooviz, the first ophthalmology biosimilar to gain FDA approval. Developed by Samsung Bioepis and Biogen, Byooviz is the first biosimilar referencing Lucentis, which treats macular degeneration, macular edema, and myopic choroidal neovascularization.

“This landmark FDA approval represents a crucial step in providing lower-cost treatment for millions of Americans, especially seniors who suffer from eye disease,” said Biosimilars Forum Executive Director Meaghan Rose Smith. “The introduction of biosimilars like Byooviz will increase competition, lower prices and provide Americans with greater access to effective treatment options. The Biosimilars Forum applauds the FDA for approving Byooviz and for verifying it is both safe and effective for those who need it.”

Byooviz demonstrated “comparative clinical efficacy and safety evaluations” to the reference product Lucentis, according to the FDA. This FDA approval is the latest example of the promise of biosimilars to expand access for treatment and options for patients in more disease states. To date, the FDA has approved 31 biosimilars, including one interchangeable biosimilar, for the treatment of a variety of health conditions.

Macular degeneration currently affects as many as 11 million Americans, and this number is expected to double to 22 million by 2050. The condition predominantly affects those over the age of 75. Macular edema affects more than 750,000 Americans, most commonly those with diabetes. Myopic choroidal neovascularization is a frequent, vision-threatening side effect of pathologic myopia, impacting up to 11% of those patients. All three conditions require biologic treatments to prevent life-altering side effects, such as blindness.

Today’s action is the latest in a string of events on Capitol Hill and in the Biden Administration in support of biosimilars. Several months ago, President Biden issued an Executive Order directing the Department of Health and Human Services to take steps to promote biosimilar competition, and bipartisan legislation in the House and Senate continues to build momentum.  

To learn more about these policy efforts, visit: