Pfizer Wants FDA To Stop Sponsor Promos From Implying Biosimilars Are Inferior
Citizen petition requests agency guidance that specifies what communications are false and misleading; Pfizer cites a Janssen Remicade brochure and Amgen YouTube video that suggest switching to biosimilars could lead to different outcomes.
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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.
The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading.
Legality Of J&J's Remicade Contracting Depends On Share Of Biosimilar Market Foreclosed, Court Rules
Court denies J&J's motion to dismiss Pfizer's antitrust suit, saying discovery will reveal whether Pfizer has offered more competitive pricing for its Inflectra biosimilar and if there are alternative causes for Pfizer's inability to gain market share.