BsUFA Agreement: Increased Communication, Staff Retention, Goal Dates For Guidances

FDA unveiled goals for the second iteration of the biosimilar user fee program Friday (Sept. 16) that include a call for more communication between applicants and the FDA review team to minimize the number of review cycles needed for approval. The goals letter also suggests industry may not see revised or final guidances for biosimilar naming, labeling and other issues until May 2019 at the latest. Pfenex, whose CEO Bert Liang also heads the Biosimilars Council, said it was encouraged...