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.
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BsUFA Suggestions From Sponsors Sound Easy, But Changes May Be Difficult For US FDA
Biosimilar sponsors want meeting and assessment best practices implemented across divisions, but the FDA says that may be difficult and time-consuming.
CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence
US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.
Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.