The U.S. Food and Drug Administration rejected Amgen Inc.'s application seeking approval for ABP 980, a biosimilar version of Herceptin.
"We will work closely with the FDA to bring this important medicine to patients in the U.S. We do not expect this to impact our U.S launch plan," Amgen said in a statement.
Herceptin, or trastuzumab, which is owned by Roche Holding AG, generated CHF 7.01 billion in sales during 2017.
