RHHBY Roche Holdings Ltd AG (QX)

By Colin Kellaher

Biogen Inc. and its Samsung Bioepis Co. venture on Monday said the U.S. Food and Drug Administration approved Byooviz, their biosimilar to Roche Holdings AG's blockbuster eye drug Lucentis.

The companies said the approval, the first in the U.S. for an ophthalmology biosimilar, covers Byooviz for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

Biosimilars are near-copies of biologic drugs that are made from living cells and are analogous to generic copies of traditional pill-form medicines.

Byooviz was developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics Co., and be commercialized in the U.S. by Biogen. The companies said Biogen would be able to market Byooviz in the U.S. as of June 2022 under a global license agreement with Roche's Genentech unit, which developed Lucentis.

Biogen and Samsung Bioepis are also pursuing a biosimilar to Regeneron Pharmaceuticals Inc.'s blockbuster eye drug Eylea.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 20, 2021 08:06 ET (12:06 GMT)

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