Amgen’s Neulasta Ad Indirectly Targeting Biosimilars Draws US FDA Rebuke
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.
You may also be interested in...
Office of Prescription Drug Promotion issued six enforcement letters and launched three research projects in 2021. There were more internal changes as the office switched to electronic submissions of promotional materials and went through year-end reorganization.
Juliana Reed, who just moved from Pfizer to head the trade group, hopes scientific advances will eventually eliminate the need for the interchangeability designation, but for now the association is educating stakeholders in preparation for the 2023 launch of Humira biosimilars.
Eton Pharmaceuticals gets untitled letter for promotion of its Alkindi Sprinkle hydrocortisone granules for treatment of pediatric adrenal insufficiency. The agency sent two letters last year objecting to sponsored links after a decade pause.