U.S. License Holder:
Date of License:
ZARXIO (filgrastim-sndz) is a leukocyte growth factor indicated to:
Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever;
Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML);
Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT);
Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis;
Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Zarzio (Sandoz) (February-2009)
Biosimilars Approved In Australia
Zarzio (Sandoz) (May-2013)
Biosimilars Approved In Japan
Filgrastim BS (Sandoz) (March-2014)
U.S. Patent LitigationsPACER
U.S. Patent Nos.
6,162,427 (Combination of G-CSF with a Chemotherapeutic Agent for Stem Cell Mobilization) 8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)
Amgen Manufacturing, Ltd.; Amgen Inc.
Sandoz International GmbH; Sandoz GmbH; Sandoz Inc.
Federal Circuit Appeal(s)
Supreme Court Appeal(s)
15-1039 (U.S.) 15-1195 (U.S.)
BPCIA Interpretation: Supreme Court Vacated-in-Part, Reversed-in-Part, and Remanded; Remand to Federal Circuit: Affirmed. Infringement and Validity: Summary Judgment of Non-infringement and Invalidity Counterclaims Dismissed; Federal Circuit Appeal Pending