Pink Sheet Podcast: Oncology Reviews, Biosimilars, and More Biosimilars
Our discussion of US FDA's two-drug Oncologic Drugs Advisory Committee meeting, the recent biosimilar insulin public hearing, and the new final biosimilar interchangeability guidance.
You may also be interested in...
US FDA still deliberating on how best to measure success of the liver safety program for Daiichi's TGCT treatment, but REMS will probably assess both process and outcomes.
Approaches suggested at a US FDA public hearing include allowing follow-on insulins to take a direct route to interchangeability without first having to be approved as biosimilars, and automatically declaring biosimilar insulins interchangeable with one or more reference products.
US FDA's Oncologic Drugs Advisory Committee voted 8-3 against approval for Daiichi's quizartinib, although panelists felt the acute myeloid leukemia candidate would be approvable with another trial to better characterize its efficacy.