Gottlieb Worried About Campaigns Against Biosimilars

FDA commissioner Scott Gottlieb says the agency is monitoring whether branded biologic companies are taking any steps to undermine the fledgling biosimilar product market. “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,” Gottlieb said in a tweet.

Gottlieb’s concern follows a recent Washington Post article highlighting FDA’s attention on actions of biologic manufacturers to spread confusion about the safety and efficacy of biosimilar products. According to the newspaper, some firms have claimed that biosimilar products could “put you in the emergency room,” carry “additional risks,” or cause “potential problems involving efficacy, safety.”