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 2 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.

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