Expert: Don’t Expect Guidance on Biosimilar Interchangeability Anytime Soon

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. The FDA will want to see how patients react to approved biosimilars before proceeding, he said, so “I’m not expecting to see much more guidance from the FDA until they get that data.”
Drug Industry Daily