Biogen : FDA Accepts Biogen, Samsung Bioepis Filing for Lucentis Biosimilar

By Colin Kellaher

Samsung Bioepis Co. and Biogen Inc. on Wednesday said the U.S. Food and Drug Administration accepted for review their biologics license application for SB11, a proposed biosimilar to Roche Holdings AG's blockbuster eye drug Lucentis.

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

Roche's Lucentis is a therapy for retinal vascular disorders, which are a leading cause of blindness in the U.S.

SB11, if approved, would join a growing number of biosimilars developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics Co., and commercialized by Biogen.

Last November, Biogen and Samsung Bioepis said they would pursue ophthalmology biosimilar candidates for Lucentis and Regeneron Pharmaceuticals Inc.'s Eylea.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

11-18-20 0736ET