Zirabev® (bevacizumab-bvzr)

aBL 761099

Zirabev® (bevacizumab-bvzr)

aBL 761099

U.S. License Holder:

Pfizer Inc.

Date of License:

June-27-2019

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

ZIRABEV (bevacizumab-bvzr) is a vascular endothelial growth factor inhibitor indicated for the treatment of:

Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment;

Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab containing regimen;

Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment;

Recurrent glioblastoma in adults;

Metastatic renal cell carcinoma in combination with interferon alfa;

Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan;

Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by Zirabev as a single agent, for stage III or IV disease following initial surgical resection; in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens; in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Zirabev as a single agent, for platinum-sensitive recurrent disease.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Zirabev® (Pfizer) (June-2019)

Biosimilars Approved In The E.U.

Zirabev® (Pfizer) (February-2019)

Biosimilars Approved In Australia

Zirabev® (Pfizer) (November-2019)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-01771

U.S. Patent No.
7,622,115 (Treatment With Anti-VEGF Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Hospira, Inc.; Pfizer Inc.

§ 102 Challenge
Y: Claims 1-5

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-5

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
18-1959

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed

IPR2018-00373

U.S. Patent No.
9,795,672 (Treatment With Anti-VEGF Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
Y: Claims 1-18

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:19-cv-00638 (D. Del.)

U.S. Patent Nos.
6,054,297 (Humanized Antibodies and Methods for Making Them) 6,121,428 (Protein Recovery) 6,242,177 (Methods and Compositions for Secretion of Heterologous Polypeptides) 6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,407,213 (Method for Making Humanized Antibodies) 6,610,516 (Cell Culture Process) 6,884,879 (Anti-VEGF Antibodies) 7,060,269 (Anti-VEGF Antibodies) 7,169,901 (Anti-VEGF Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,622,115 (Treatment With Anti-VEGF Antibodies) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,846,336 (Chromatographic Methods) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 8,314,225 (Heavy Chain Mutant Leading to Improved Immunoglobulin Production) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media) 9,795,672 (Treatment with Anti-VEGF Antibodies) 9,884,904 (Method for Purifying Polypeptide Solutions) 10,010,611 (Antibody Formulations)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Pfizer Inc.

Status
Stipulated Dismissal Due to Settlement

BPCIA
Y

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Methodology

Information contained in the Venable 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 BiologicsHQ database.

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