October 1, 2023
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FDA accuses Amgen of misleading advertising


The U.S. Food and Drug Administration tagged Amgen with a letter July 7 that says the Thousand Oaks biotech firm made “misleading claims” in advertisements for its drug Neulasta, by suggesting it is more effective than biosimilar competitors.

Neulasta is a prescription medication used to reduce infection risk from febrile neutropenia (a low level of a certain type of white blood cell) in people with certain types of cancer.

In the letter, the FDA’s Office of Prescription Drug Promotion criticized Amgen ads that could “cause healthcare providers to conclude that Neulasta delivered via the Onpro on-body injector is more effective than Neulasta delivered via prefilled syringe.”

This, in turn, could suggest that delivering Neulasta via Onpro on-body injector is more effective than FDA-licensed biosimilar products which are only delivered via prefilled syringes. Studies of Neulasta do not support that conclusion, the letter said.

In response to the letter, Amgen told the Business Times via a statement that it will “work with the FDA to ensure we are in compliance with the FDA regulations on this matter.”

According to the FDA letter, the biggest problem with the advertisement was that Amgen cited a “real-world study” with nearly 11,000 patients which showed that using pre-filled syringes resulted “in a significantly higher risk” of febrile neutropenia. Amgen cited a statistic from the same study that said “with pre-filled syringes, febrile neutropenia increased by 31% vs. Onpro.”

The FDA said this was false, adding that the study Amgen cited had “multiple limitations.”

One such limitation was the fact that the study was not designed to ensure that patients with febrile neutropenia were appropriately identified for inclusion in the analysis, the FDA said.

Biolsimiars for Neulasta in the United States include Pfizer’s Nyvepria, Novartis Sandoz’s Ziextenzo, and Mylan and Biocon’s Fulphila. Since those and other biosimilars have come onto the scene, Amgen has seen a reduction in Neulasta sales.

In fiscal year 2020, Neulasta sales dropped 29% year-over-year, with the drug generating just over $2 billion in 2020. In the first quarter of 2021, sales dipped 21% year-over-year as the drug had $421 million in sales.

The most recently published average selling price for Neulasta in the U.S. has declined 30% year-over-year and 9% quarter-over-quarter, due to an increase in biosimilars.

The company has stated that going forward, they expect even more biosimilars, resulting in additional net price erosion.

Amgen has currently invested more than $2 billion into biosimilars and has 10 biosimilars in their development portfolio, which includes multiple global approvals and launches.   

Amgen’s stock opened at $248.08 July 16. Since the beginning of the year, Amgen shares are up 9.5%.