From the get-go, the 7 January meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC) was a lovefest between regulators and the filgrastim biosimilar from Novartis and its Sandoz unit, known as Zarxio, which won the panel's unanimous support.
Indeed, Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation & Research (CDER), greeted meeting attendees by declaring...






