Udenyca (pegfilgrastim-cbqv)

aBL 761039

Udenyca (pegfilgrastim-cbqv)

aBL 761039

U.S. License Holder:

Coherus

Date of License:

November-02-2018

Last Update:

June-30-2020

approved_indications FDA-Approved Indications

UDENYCA (pegfilgrastim-cbqv) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Udenyca (Coherus Biosciences) (September-2018)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:17-cv-00546 (D. Del.)

U.S. Patent Nos.
8,273,707 (Process for Purifying Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Coherus Biosciences Inc.

Federal Circuit Appeal(s)
18-1993

Status
Dismissed for Failure to State a Claim; Federal Circuit Affirmed

BPCIA
Y

56-2017-00493553-CU-BT-VTA (CA Sup. Ct.)

U.S. Patent Nos.
[None Listed]

Plaintiffs
Amgen Inc.

Defendants
Coherus Biosciences Inc.

Status
Settled

BPCIA
N

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – January 2019 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. February 11, 2019
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – November 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. December 11, 2018

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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