Amgen Pulled Up Over Anti-Biosimilar Pegfilgrastim Promotion
FDA Cautions Originator Over ‘Misleading’ Claims On Neulasta Onpro
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.
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Apobiologix’s new Lapelga autoinjector that the firm has just introduced in Canada is only the second on-body pegfilgrastim device to launch after Amgen’s Neulasta original.
Pfizer’s Nyvepria biosimilar was the fourth pegfilgrastim biosimilar approved by the FDA, despite ongoing litigation from originator Amgen. The biosimilar sponsor has cleared any niggling legal issues by settling litigation over a US patent directed at methods of protein purification.
Amgen has once again touched on its impending expansion into US inflammation/immunology biosimilars, with launches for adalimumab and ustekinumab scheduled for the coming years.