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, including 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.”
With so little guidance and so much at stake, don’t be in the dark on what you can do now to stay ahead in the biosimilars game.
FDAnews has called on two experts to explain what the FDA is trying to do, how the public comments might change the landscape and what you need to know NOW in order to stay out in front.