In a tweet today, FDA Commissioner Scott Gottlieb stated: “FDA continues to be concerned about branded companies creating confusion about the safety and effectiveness of biosimilars and we’ll take action if we determine a company is deliberately misleading the public about the safety of these important products.” The communication comes in response to an article by the Washington Post yesterday concerning the US government’s focus on actions of biologics manufacturers that may be seen as calling into question the safety and efficacy of biosimilar products. The article reported that “[h]ealth-care and government officials are growing concerned that the makers of the most advanced drug therapies are using scare tactics to ward off emerging generic versions of their products.” The article also described Pfizer’s citizen petition to FDA, which, as we previously reported, seeks guidance from FDA about appropriate sponsor communications concerning the efficacy of biosimilars.
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