ARTICLE | Regulation

Pathway to interchangeability

FDA's Woodcock lays out path for biosimilars to be interchangeable

October 13, 2014 7:00 AM UTC

Four and a half years after the U.S. biosimilars pathway was officially created, it is finally getting some traffic - at least two applications are under review - but critical regulatory and commercial issues remain murky. In an interview with BioCentury This Week television, Janet Woodcock, director of the Center for Drug Evaluation and Research, shed light on FDA's thinking about some of the most pressing topics: interchangeability, extrapolation of indications, and naming policies.

Addressing one of the most contentious issues in biosimilars development, Woodcock said the threshold for obtaining interchangeability designation will be higher than for obtaining approval as a biosimilar, but the bar won't be insurmountable. ...