STAT+: FDA scolds Amgen over a misleading ad that could deter use of biosimilar versions of its drug
In an embarrassing rebuke, the Food and Drug Administration has scolded Amgen (AMGN) over a drug advertisement 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 than an injector placed on the patient’s body. Amgen markets the OnPro injector kit, which was the subject of the animated ad.
