FDA And FTC Join Forces On Biosimilars
Teaming Up 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.
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FDA And FTC Continue To Collaborate On Biosimilar Competition
The FDA and FTC have been working on improving information exchange about activities which could undermine biosimilar competition, as well as addressing misinformation about factors such as interchangeability.
Amgen Pulled Up Over Anti-Biosimilar Pegfilgrastim Promotion
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.
AmerisourceBergen Sees Momentum Build In US Biosimilars
AmerisourceBergen’s senior director of biosimilars, Sean McGowan, believes that momentum is continuing to build for US biosimilars in 2021, especially with key developments involving insulins and interchangeability on the horizon.