Benzinga | Jul 15, 2021 12:19PM EDT

FDA Rebukes Amgen Over Misleading Branding Of Neulasta

* The FDA has issued an untitled letter to Amgen Inc (NASDAQ: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.