FDA Accepts Avastin Biosimilar BLA From Biogen, Samsung BioLogics Venture

Date : 11/19/2019 @ 1:45PM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 38.4  0.005 (0.01%) @ 9:12PM
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FDA Accepts Avastin Biosimilar BLA From Biogen, Samsung BioLogics Venture

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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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