FDA, FTC Join Forces To Eliminate Barriers To Biosimilar Competition
Two agencies to take action against false or misleading communications about biosimilars, impediments to sampling, and anticompetitive patent settlement agreements; to hold public workshop in March.
You may also be interested in...
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.
‘Rebate walls’ report heads to US Congress, but Democratic commissioners suggest FTC’s typical approach to curtailing such practices is too time consuming.
Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.