Biogen, Samsung Bioepis Get FDA OK for Lucentis Biosimilar
September 20 2021 - 8:21AM
Dow Jones News
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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