FDA Approves Herceptin Biosimilar Herzuma
14 Décembre 2018 - 11:57PM
Dow Jones News
By Maria Armental
A biosimilar of Roche Holding AG's (ROG.EB) blockbuster
breast-cancer drug Herceptin has been approved for sale in the
U.S., health regulators said Friday.
The medicine, Herzuma, is manufactured by South Korea's
Celltrion Inc. (068270.SE) and would be sold in the U.S. by Teva
Pharmaceuticals Inc. (TEVA, TEVA.TV).
The Food and Drug Administration has pushed for the development
of biosimilars, which are lower-cost copies of complex and often
expensive biotech drugs, as part of efforts to lower drug
prices.
Roche's Herceptin, also known by the generic name trastuzumab,
gained FDA approval in 1998.
Herceptin accounted for more than $3 billion in sales for the
first half of this year, up 2% from the comparable period a year
earlier. Sales were helped during that period with 12% growth in
the U.S., according to Roche's financial documents.
In October, Swiss pharmaceuticals maker Roche said it expected
less of an effect on U.S. sales from biosimilars than in
Europe.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
December 14, 2018 17:42 ET (22:42 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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