BsUFA Suggestions From Sponsors Sound Easy, But Changes May Be Difficult For US FDA
Executive Summary
Biosimilar sponsors want meeting and assessment best practices implemented across divisions, but the FDA says that may be difficult and time-consuming.
You may also be interested in...
Tentative Biosimilar Approvals Under Consideration By FDA
Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.
Tentative Biosimilar Approvals A Consideration for the US FDA
Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.
For Biosimilars, A Mid-Review Cycle Product Quality Discussion Appears To Be A Bad Omen
Only about one-third of biosimilars received a first-cycle approval from US FDA after product quality discussions during the mid-assessment-cycle meeting, according to an interim report on the biosimilar application review program.