FDA Accepts Avastin Biosimilar BLA From Biogen, Samsung BioLogics Venture
November 19 2019 - 8:45AM
Dow Jones News
By Colin Kellaher
Samsung Bioepis Co. on Tuesday said the U.S. Food and Drug
Administration accepted for review its biologics license
application for SB8, a biosimilar to Roche Holdings AG's (ROG.EB)
cancer drug Avastin.
The joint venture of Samsung BioLogics Co. (207940.SE) and
Biogen Inc. (BIIB) submitted the BLA in September.
Biosimilars are near-copies of biologic drugs, such as Avastin,
that are made from living cells and are analogous to generic copies
of traditional pill-form medicines.
Samsung Bioepis said SB8, if approved, will be commercialized in
the U.S. by Merck & Co. (MRK) under a 2013 collaboration
agreement.
Amgen Inc. (AMGN) and Allergan PLC (AGN) in July jointly
launched the first biosimilar to Avastin in the U.S., and Pfizer
Inc. (PFE) has said it plans to launch its own Avastin biosimilar
on Dec. 31.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 19, 2019 08:30 ET (13:30 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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