FDA approves first ophthalmology biosim

Sept. 20, 2021

Biogen and Samsung Bioepis announced that the U.S. FDA approved Byooviz, their biosimilar to Roche Holding's blockbuster eye drug Lucentis, marking the first ophthalmology biosimilar approved in the United States.

The news comes just 3 weeks after the biosimilar received marketing authorization from the European Commission.

Byooviz, an anti-vascular endothelial growth factor (VEGF) therapy, was approved for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization. In the U.S., approximately 11 million people are affected by AMD.

Lucentis sales for Roche, though declining, still reached $1.61 billion in 2020.

The approval is the result of an agreement between Samsung Bioepis and Biogen made back in Nov 2019. The agreement was for two ophthalmology biosimilar candidates — a biosimilar candidate referencing Roche's Lucentis and a biosimilar candidate referencing Regeneron's Eylea. Byooviz was developed by Samsung Biospis and will be commercialized by Biogen in the U.S.

Read the press release