FDA Releases Biosimilars Guidelines to Little Fanfare

摘要

On February 9, FDA issued long-awaited guidelines designed, according to FDA drug division director Janet Woodcock, M.D., "to help industry develop biosimilar versions of currently approved biological products." Paul Calvo, Ph.D., a director at Sterne, Kes-sler, Goldstein & Fox, told GEN, "There were no major surprises" in the guidelines. "It is clear that FDA wants to move forward with biosimilar approvals and they will be looking to a totality of the evidence as the standard for a determination ofbiosimilarity." He also commented that FDA wants a constant dialog with biosimilar sponsors and all the structural and functional data up front. "Their goal for the up-front data is to be involved in design of the clinical trials in order to maximize the data provided."