In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a review model similar to “the Program” initiated under the Prescription Drug User Fee Act (PDUFA). Highlights include a mid-cycle communication, a late-cycle…
Today, the FDA released the latest version of its Guidance Agenda for the upcoming year. Among the new and revised draft guidances that CDER plans to release are the following three guidances concerning biosimilarity: Considerations in Demonstrating Interchangeability With a Reference Product Labeling for Biosimilar Products Statistical Approaches to Evaluation…