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Amgen Pulled Up Over Anti-Biosimilar Pegfilgrastim Promotion

FDA Cautions Originator Over ‘Misleading’ Claims On Neulasta Onpro

Executive Summary

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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Biocon Waits On FDA Insulin Inspection

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The Wait For Inspections: Biocon Seeks FDA Stance On Mutual Recognition Agreement Route

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