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Amgen Statement on Complete Response Letter from the U.S. FDA for ABP 980, a Biosimilar Candidate to Herceptin® (Trastuzumab)

Amgen received a complete response letter from the United States (U.S.) Food and Drug Administration (FDA) in response to the Biologics License Application (BLA) for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab).

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.