Pink Sheet Podcast: Oncology Reviews, Biosimilars, and More Biosimilars
Executive Summary
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.
Senior writers Derrick Gingery and Michael Cipriano discuss the interesting regulatory issues that emerged during the Oncologic Drugs Advisory Committee 14 May meeting involving two Daiichi Sankyo Co. Ltd. cancer drugs, as well as the US Food and Drug Administration's recent biosimilar insulin hearing and its release of final biosimilar interchangeability guidance.
More On These Topics From The Pink Sheet:
Defining REMS Success An Unanswered Question For Daiichi's Pexidartinib
Quizartinib Looks Like A Good Drug, ODAC Says, But Needs Another Efficacy Trial Before Approval
Best Pathway To Interchangeable Insulins Is In The Eye Of The Beholder
Biosimilar Interchangeability Switching Studies May Use Foreign Comparators, US FDA Says