Amgen ads talking up its Neulasta on-body injection system caught the FDA’s attention—with the help of some “Bad Ad” tattlers.
The FDA slapped Amgen with an untitled letter last week for banner ad claims about its on-body injection system, a feature it's using to compete against biosimilars.
The agency's Office of Prescription Drug Promotion (OPDP) pointed to Amgen ads for physicians that claimed its Onpro on-body injector was superior to Neulasta supplied in pre-filled syringes—as well as biosimilar versions of pegfilgrastim, which are only approved for pre-filled syringe delivery.
While the FDA reviewed the advertising itself, similar complaints were received through its “Bad Ad” reporting program, the agency said. The FDA’s Bad Ad Program allows consumers, doctors and competitors to report drug advertising that may not be following guidelines.
Neulasta faces several biosimilar competitors in the U.S., including Pfizer’s Nyvepria, Novartis Sandoz’s Ziextenzo, and Mylan and Biocon’s Fulphila.
The nitty-gritty of the problem? Amgen claimed in the ads that a real-world study of almost 11,000 patients using pegfilfrastim pre-filled syringes resulted “in a significantly higher risk” of febrile neutropenia. In another banner ad, it said febrile neutropenia “increased by 31% vs. Onpro.”
FDA slapped that down, saying the study Amgen cited had “multiple limitations" that "preclude the drawing of such conclusions regarding the comparative risk of febrile neutropenia in patients taking pegfilgrastim depending on delivery method.”
Amgen acknowledged the letter in a statement to Fierce Pharma and said it's working with the FDA to make sure it's in compliance.
However, Amgen also noted that "there is a robust body of clinical and real-world evidence that demonstrates that when used every cycle, Neulasta significantly reduced the incidence of febrile neutropenia (FN) as well as FN-related events, including FN-related hospitalization and the use of anti-infective drugs in patients undergoing chemotherapy."
The Amgen letter is only the second sent by OPDP in 2021 in an ongoing trend of fewer reprimands in recent years. In 2020, the agency sent six letters, although five of those were warning letters. In 2019, the promo police sent 10 letters.
Several of the letters dispatched in 2020 and 2019 have since been removed from the FDA's website.