Zarxio® (filgrastim-sndz)

aBL 125553

Zarxio® (filgrastim-sndz)

aBL 125553

U.S. License Holder:

Sandoz Inc.

Date of License:


Last Update:


approved_indications FDA-Approved Indications

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_indications 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)

approved_indications U.S. Patent Litigations


Case No(s):

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)
15-1499 18-1551

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 Affirmed, Petition for En Banc Rehearing Granted-in-Part and Denied-in-Part


U.S. Patent Nos.
9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Sandoz, Inc.

Amgen Manufacturing, Ltd.; Amgen Inc.

Voluntarily Dismissed



Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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