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RHHBY Roche Holdings Ltd AG (QX)

29.83
0.57 (1.95%)
03 May 2024 - Closed
Delayed by 15 minutes
Name Symbol Market Type
Roche Holdings Ltd AG (QX) USOTC:RHHBY OTCMarkets Depository Receipt
  Price Change % Change Price Bid Price Offer Price High Price Low Price Open Price Traded Last Trade
  0.57 1.95% 29.83 29.78 29.86 30.08 29.715 30.04 4,829,456 21:22:28

FDA Accepts Avastin Biosimilar BLA From Biogen, Samsung BioLogics Venture

19/11/2019 1:45pm

Dow Jones News


Roche (QX) (USOTC:RHHBY)
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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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