ODAC meeting, data for Sandoz's filgrastim biosimilar

FDA's Oncologic Drugs Advisory Committee will meet Jan. 7 to discuss a BLA from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) for EP2006, a biosimilar version of Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGN). FDA accepted Sandoz's BLA for the recombinant methionyl human granulocyte colony-stimulating factor in July, making it the first disclosed biosimilar application to be reviewed by the agency.

Separately, Sandoz said on Monday that it reported data from the Phase III PIONEER study to prevent severe neutropenia in breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy. Sandoz said the results demonstrated its product has similar efficacy and safety compared with Neupogen, and showed that repeated switching at each cycle between the biosimilar and Neupogen showed no impact on efficacy, safety or immunogenicity. Data were presented at the 56th American Society of Hematology meeting in San Francisco. ...