FDA panel backs approval of filgrastim biosimilar
AT AN FDA ADVISORY COMMITTEE MEETING
Cost is not allowed to be discussed during FDA panel meetings, and Sandoz did not specify any possible price of the biosimilar, but this issue was the “elephant in the room,” as one panelist pointed out. However, Dr. Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University in Washington, who spoke on behalf of Sandoz at the meeting, said that the availability of the filgrastim biosimilar has “enormous promise in reducing cost and expanding access” to this treatment. Although it has “unquestioned clinical value,” he said that granulocyte colony-stimulating factor therapy is underused.
The five indications approved for Neupogen are to decrease the incidence of infection‚ as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever; for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia; to reduce the duration of neutropenia and neutropenia-related clinical sequelae; for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and for chronic administration to reduce the incidence and duration of sequelae of neutropenia in symptomatic patients with congenital‚ cyclic‚ or idiopathic neutropenia.
The FDA usually follows the recommendations of its advisory panels. Panelists were cleared of potential conflicts of interest related to the topic of the meeting. In some cases, a panelist may be given a waiver but not at this meeting. Dr. Weiner’s disclosure included being a consultant to Sandoz.
