FDA Mulls Policy Switch on Switching Study Requirement for Biosimilars
The FDA is considering a change in biosimilar policy that could make things a lot easier for a whole host ...
Monday, January 6, 2025
Tag: biosimilars
FDA’s Biosimilars Action Plan
In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for ...
Are providers ready for biosimilars?
Perhaps more education is needed. That is the conclusion from a paper by Giovatto et ...
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs
A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday ...
Utilization management for biosimilars
When we think of utilization management (e.g., prior authorizations, step edits), we often think payers only use these for higher ...
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