FDA Approves Herceptin Biosimilar Ontruzant Breast Cancer Drug
January 18 2019 - 3:24PM
Dow Jones News
By Maria Armental
U.S. health regulators have approved another so-called
biosimilar to Roche Holding AG's (ROG.EB) blockbuster breast-cancer
drug Herceptin.
Ontruzant, which was developed by South Korea's Samsung Bioepis
Co. and would be sold in the U.S. by Merck & Co., is the third
Herceptin biosimilar approved by the Food and Drug
Administration.
Biosimilars, lower-cost copies of complex and often expensive
biotech drugs, are a key part of the FDA's push to lower drug
prices.
Roche's Herceptin, also known by the generic name trastuzumab,
gained FDA approval in 1998.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
January 18, 2019 15:09 ET (20:09 GMT)
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