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Biotech Stocks Facing FDA Decision In September 2021

Biogen
Biogen

The FDA decision on Biogen Inc.’s (BIIB) SB11, a proposed biosimilar to Roche’s Lucentis, is expected on September 18.

Roche’s Lucentis is approved in the U.S. for wet age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy. The drug generated annual sales of $1.61 billion in the U.S. in 2020, down 16% from 2019.

SB11 was developed by Samsung Bioepis Co., Ltd., a joint venture between Samsung BioLogics and Biogen. Last May, Biogen entered into a commercialization agreement with Samsung Bioepis for SB11 in the U.S., Canada, Europe, Japan, and Australia.

If approved, SB11 could be the first US Lucentis biosimilar.

BIIB closed Friday’s trading at $343.19, up 0.28%.