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Amgen Pulled Up Over Anti-Biosimilar Pegfilgrastim Promotion

FDA Cautions Originator Over ‘Misleading’ Claims On Neulasta Onpro

 
• By Dave Wallace

Amgen has been rebuked by the FDA over promotion for its unique Neulasta Onpro on-body injector version of pegfilgrastim, in which the firm made false or misleading claims about its benefit compared to a pre-filled syringe formulation of pegfilgrastim, where biosimilar competition exists.

Amgen was rebuked by the FDA over promotion for its Neulasta Onpro • Source: illustration/FDA

Amgen has been pulled up by the US Food and Drug Administration over promotion for its Neulasta Onpro on-body injector version of pegfilgrastim, which the agency said “makes false or misleading claims and representations about the benefit of Neulasta when administered through the Onpro on-body injector compared to a pre-filled syringe.”

Neulasta currently holds around two-thirds of the US pegfilgrastim market despite biosimilar competition, with the bulk of this coming from the Onpro on-body injector device that represents just over half of the pegfilgrastim market. (Also see "Coherus Distances Itself From Biosimilar Interchangeability" - Generics Bulletin, 7 May, 2021

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