FDA moving forward on biosimilars

FDA has completed work on biosimilars guidance documents and expects them to be released "promptly," Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told BioCentury This Week, BioCentury's public affairs television program. In an interview that will be posted online Sunday, Woodcock described approval criteria for biosimilars, which will be based first on evaluation of analytical similarity to an innovator, with that evaluation driving FDA's requirements for clinical data. She said that using this approach, creating an "interchangeable biosimilar is feasible." ...