FDA Rebukes Amgen Over Misleading Branding Of Neulasta - Amgen (NASDAQ:AMGN)

The FDA has issued an untitled letter to Amgen Inc AMGN for the misbranding of its blockbuster bone marrow stimulant, Neulasta (pegfilgrastim) injection.
Amgen released a promotional communication that makes false or misleading claims and representations about the benefit of Neulasta when administered through the Onpro on-body injector compared to a prefilled syringe (PFS).
Amgen used an unvalidated algorithm with unknown performance characteristics and the fact that the study was not balanced or controlled for potential bias, the FDA notes.
And while Amgen does note two limitations to the study, the agency adds that the mentions do not mitigate the misleading claims and presentations in the banner.
“The above misleading claims and presentations are concerning 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,” the FDA said.
Neulasta is the reference product for all FDA-licensed biosimilar pegfilgrastim products, which are only available as a prefilled syringe.
Amgen has already been impacted by competition from biosimilars. Q1 2021 Neulasta fell 21% Y/Y to $482 million, as its average U.S. price slipped 30% Y/Y and 9% sequentially.
Price Action: AMGN shares are up 0.50% at $245.93 during the market session on the last check Thursday.