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Amgen’s Neulasta Ad Indirectly Targeting Biosimilars Draws US FDA Rebuke

 
• By Brenda Sandburg

Animated banner ad claiming administration of Neulasta with Amgen’s Onpro on-body injector has less risk of febrile neutropenia than administration via prefilled syringe draws untitled letter and a rare press release. FDA says claims could undermine confidence in biosimilar pegfilgrastim products.

FDA objects to Amgen's Neulasta promotion • Source: illustration/FDA

The US Food and Drug Administration issued a typical untitled letter to Amgen, Inc. objecting to an ad with claims suggesting that delivery of Neulasta (pegfilgrastim) via its Onpro on-body injector is superior to Neulasta delivered via prefilled syringe or to biosimilar pegfilgrastim products. But the agency added more sting to the reprimand by issuing a press release spotlighting the letter.

The Office of Prescription Drug Promotion said Amgen’s professional animated banner for Neulasta injection makes claims and presentations that create a misleading impression regarding the benefit of the Onpro product by stating that there is a statistically significant higher risk of febrile neutropenia (FN) when pegfilgrastim is administered via the prefilled syringe compared to the Onpro on-body injector. The

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