Advising the advisors

FDA used last week's panel review of Zarxio, a G-CSF product from the Sandoz unit of Novartis AG, to instruct the public, the Oncologic Drugs Advisory Committee and other committees on how to consider the data packages for biosimilars. In addition to educating the panel, the review of the first-ever biosimilars application provided a concrete example of how the agency and ODAC view extrapolation of clinical data for biosimilars, at least for a product that has been marketed for several years in Europe.

Sandoz is seeking approval for Zarxio as a biosimilar of Amgen Inc.'s Neupogen filgrastim, including all five indications for which Neupogen is approved: to treat cancer patients receiving myelosuppressive chemotherapy; patients with acute myelogenous leukemia (AML) receiving induction or consolidation chemotherapy; cancer patients receiving bone marrow transplant; patients undergoing peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia...