FDA Cautions Amgen Against Advertisements Misrepresenting Neulasta Onpro as Superior to Biosimilars


Amgen has received a letter from the FDA cautioning it against making misleading claims in advertising about its pegfilgrastim injector.

The FDA issued a letter to Amgen after receiving complaints regarding the company’s advertisements for Neulasta Onpro, its wearable injector for reference pegfilgrastim. The agency received the complaints through its Bad Ad Program.

The wording used in the advertisements claimed that the Onpro is more successful at reducing patients’ risk of developing febrile neutropenia (FN), a common complication associated with chemotherapy treatments. However, the FDA determined that these claims are misleading.

“These violations are concerning from a public health perspective because this promotional communication’s misleading claims could cause health care providers to conclude that Neulasta delivered via the Onpro on-body injector is more effective than Neulasta delivered via [prefilled syringe (PFS)] or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS,” the FDA wrote in the “untitled letter,” which is 1 action below a warning letter intended to point out noncompliance with regulatory standards.

The agency said that the study Amgen based its claim on was not constructed in a way that could reliably compare FN incidence between patient treatment groups using the Onpro device vs a PFS version. The FDA also said that the claims made in the advertisements may misrepresent the efficacy of Neulasta Onpro as being superior to competing pegfilgrastim biosimilars. All pegfilgrastim biosimilars are offered in a PFS.

According to the FDA, the advertisements did not make clear that Amgen’s originator pegfilgrastim, Neulasta, is also offered in a PFS. Therefore, the company’s use of the nonproprietary name, pegfilgrastim, could diminish perceptions about the efficacy of FDA-licensed biosimilars that have been proven to be clinically similar in terms of safety and efficacy to the reference product.

“The study cited is inadequately designed and precludes the drawing of conclusions regarding the comparative risk of FN in patients taking Amgen’s pegfilgrastim products depending on delivery method. It likewise does not support conclusions about any other FDA-licensed pegfilgrastim products,” wrote the FDA.

Other claims that the FDA took issue with included:

  • “In a real world study with nearly 11,000 patients, pegfilgrastim PFS resulted in a significantly higher risk of FN vs Onpro.”
  • "Across all cycles of chemotherapy, the incidence of FN associated with PFS was 1.7% (n = 455) vs 1.3% (n = 126) for Neulasta Onpro.”
  • “With PFS, FN incidence increased by 31% vs Onpro.”

The FDA cited the unvalidated algorithm chosen to select study participants and the limitations listed in the retrospective study as further evidence that Amgen’s assertions are inaccurate.

“The data on file does not describe any measures taken to ensure the quality and accuracy of the results generated by the algorithm. As a result, the extent of FN in this study population may be overestimated or underestimated,” said the agency.

Amgen was instructed to submit a written response to the FDA’s letter within 15 days to address the agency’s concerns. The response gives Amgen an opportunity to defend its reasoning and produce evidence that supports the claims made in the advertisement.

The FDA said that Amgen has made similar statements before in other advertisements and asked the company to correct them.

Read more about this issue here.

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