Gottlieb: FDA Writing Laxer Biosimilar Interchangeability, Communication Rules

FDA Commissioner Scott Gottlieb provided the first indications Thursday (April 19) as to what policies are likely to be included in his upcoming plan to boost biosimilar development, namely lowering the bar for demonstrating interchangeability and making it easier for biosimilars to extrapolate across indications -- moves that track with a White House drug pricing report put out earlier this year. The commissioner, whose remarks come just days before the White House is slated to announce a plan to reduce...