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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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.
Biocon needs a pre-approval inspection for insulin aspart at its facility in Malaysia, but the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.