FDA rebukes Amgen for misbranding its Neulasta

The Food and Drug Administration (FDA) has issued an untitled letter to US biotech giant Amgen (Nasdaq: AMGN) for the misbranding of its biological product, Neulasta (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication.

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. 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, reporting that full-year 2020 Neulasta sales were down 29% at $2.3 billion, compared with $3.2 billion in 2019.