EMA Accepts Biogen, Samsung Bioepis Filing for Lucentis Biosimilar
October 06 2020 - 8:40AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 06, 2020 08:25 ET (12:25 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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