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.
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US Federal Trade Commission has mainly focused in pay-for-delay cases over the past decade, but pricing strategies are an emerging area of attention; industry is paying close attention to potential enforcement in biosimilar market.
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.
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.