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

By Colin Kellaher

Biogen Inc. and its Samsung Bioepis Co. venture on Tuesday said the European Medicines Agency accepted their marketing authorization application for SB11, a proposed biosimilar to Roche Holdings AG's blockbuster eye drugs 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. If approved, SB11 would join a growing number of biosimilars developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics Co., and commercialized by Biogen.

Lucentis was developed by Roche's Genentech unit and is marketed in Europe by Novartis AG. The European patent on Lucentis expires in 2022.

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

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

10-06-20 0825ET