FDA scolds Amgen over a misleading ad that could deter biosimilar use

In an embarrassing rebuke, the Food and Drug Administration has scolded Amgen (AMGN) over an advertisement for one of its medicines that made misleading claims and, as a result, might confuse physicians and thwart the use of lower-cost biosimilar versions.

The agency noted that a banner ad for the Neulasta bone marrow stimulant cited a study claiming there is a statistically significant higher risk of developing febrile neutropenia — a life-threatening complication of cancer treatment — when using a pre-filled syringe rather than an injector placed on the patient’s body. Amgen markets the OnPro injector kit, which was the subject of the animated ad.

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