From Specialty Pharmacy News - Multiple sources tell SPN that the release of biosimilars guidance is imminent, but as of SPN’s Jan. 3 deadline, the expected guidance had not yet been issued. The FDA, though, last month released proposed recommendations for a biosimilars user fee program that echoed those under the Prescription Drug User Fee Act (PDUFA). Gillian Woollett, Ph.D., vice president at Avalere Health LLC, says the FDA “has promised to soon publish three draft… Read more