Biosimilar Interchangeability Help Not Coming Anytime Soon: Expert

Drugmakers looking to branch into biosimilars shouldn’t raise their hopes for quick FDA guidance on achieving interchangeability status. The FDA’s forthcoming final guidances on biosimilars will likely look much like February’s drafts, and the agency will probably remain quiet about its next steps, such as clarifying its stance on interchangeability, Bruce Babbitt, Parexel biotechnology consultant, said.
Washington Drug Letter