Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

July 26, 2021 – The FDA’s Office of Prescription Drug Promotion (OPDP) cited Amgen for making misleading claims that the delivery of its product Neulasta® through the Onpro® on-body injector is more effective than delivery through the pre-filled syringe (PFS) or is more effective than FDA-licensed biosimilars, which are only available through PFS.

OPDP takes aim at claims made by Amgen in a professional animated banner for Neulasta (pegfilgrastim) – submitted through the Form FDA 2253 process – and states that it also received complaints about similar Amgen claims through the agency’s “Bad Ad Program.”

Claims and presentations on the banner “create a misleading impression regarding the benefit of the product by stating that there is a statistically significant higher risk of febrile neutropenia … when pegfilgrastim is administered via the prefilled syringe … compared to the Onpro on-body injector (OBI),” OPDP states in the Untitled Letter issued earlier this month.

OPDP also states that “the multiple limitations of the study cited” to support these claims “preclude the drawing of such conclusions regarding the comparative risk of febrile neutropenia on patients taking pegfilgrastim depending on delivery method.” Specifically, OPDP states that the study’s issues include design and analytic strategy limitations.

Amgen’s cited misleading claims and presentations “are particularly concerning from a public health perspective because they could undermine confidence not just in Neulasta delivered via PFS but also in FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS.”

Although OPDP concedes that Amgen states in one frame of the animated banner that the study cited evaluates Neulasta Onpro versus Neulasta PFS, “this statement is not sufficient to mitigate the more prominent presentation of Pegfilgrastim PFS vs. Neulasta Onpro and Onpro.”

OPDP states that prescription drug promotional communications misbrand a drug if they are false or misleading with respect to benefits. “The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.”

This Untitled Letter is the second one issued by OPDP in 2021; by this time last year, OPDP had issued zero Untitled Letters. OPDP has issued two Warning Letters to date in 2021, compared with just one by this date in 2020.