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 : 38.395  -0.175 (-0.45%) @ 9:05PM
Roche Holding (QX) share price Chart
After Hours
Last Trade
Last $ 38.41 ▲ 0.01 (0.04%)

FDA Accepts Avastin Biosimilar BLA From Biogen, Samsung BioLogics Venture

Roche Holding (QX) (USOTC:RHHBY)
Historical Stock Chart

1 Month : From Nov 2019 to Dec 2019

Click Here for more Roche Holding (QX) Charts.

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.

Latest RHHBY Messages

{{bbMessage.M_Alias}} {{bbMessage.MSG_Date}} {{bbMessage.HowLongAgo}} {{bbMessage.MSG_ID}} {{bbMessage.MSG_Subject}}

Loading Messages....


No posts yet, be the first! No {{symbol}} Message Board. Create One! See More Posts on {{symbol}} Message Board See More Message Board Posts
Your Recent History
LSE
GKP
Gulf Keyst..
LSE
QPP
Quindell
FTSE
UKX
FTSE 100
LSE
IOF
Iofina
FX
GBPUSD
UK Sterlin..
Stocks you've viewed will appear in this box, letting you easily return to quotes you've seen previously.

Register now to create your own custom streaming stock watchlist.

NYSE, AMEX, and ASX quotes are delayed by at least 20 minutes.
All other quotes are delayed by at least 15 minutes unless otherwise stated.

By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions

P: V:us D:20191210 01:26:33