Zarxio® (filgrastim-sndz)

aBL 125553

Zarxio® (filgrastim-sndz)

aBL 125553

U.S. License Holder:

Sandoz Inc.

Date of License:

March-06-2015

Last Update:

November-30-2018

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

PACER

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)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
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.)

Status
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

BPCIA
Y

related articles Related News Articles


Supreme Court Hears Oral Argument in Sandoz Inc. v. Amgen Inc. Brendan M. O'Malley, Ph.D.; Jacob T. Whitt, Ph.D. April 27, 2017
180-Day Advance Notice Of First Commercial Marketing Is Mandatory For All Biosimilar Applicants Robert S. Schwartz, Ph.D.; Corinne E. Atton; Frederick C. Millett; Erica L. Norey July 7, 2016
The Amgen v. Sandoz BPCIA Decision Stands: the Federal Circuit Denies an En Banc Rehearing Lawrence S. Perry; H. Rachael Million-Perez October 22, 2015
Amgen v. Sandoz: Divided Federal Circuit Attempts to Unravel the BPCIA Alicia A. Russo; Erin J.D. Austin September 1, 2015
Federal Circuit Halts Market Launch of the First U.S. Biosimilar Robert S. Schwartz, Ph.D.; Corinne E. Atton May 12, 2015
The FDA Approves Zarxio® Opening the Door to the U.S. Biosimilars Market Robert S. Schwartz, Ph.D.; Corinne E. Atton March 6, 2015

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). 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 (www.fda.gov). 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 Fitzpatrick BiologicsHQ database.

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