Avastin® (bevacizumab)

BL 125085

Avastin® (bevacizumab)

BL 125085

U.S. License Holder:

Genentech

Date of License:

February-26-2004

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


AVASTIN (bevacizumab) is a vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of:

Metastatic colorectal cancer, with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment;

Metastatic colorectal cancer, with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-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 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 Avastin 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 Avastin as a single agent, for platinum-sensitive recurrent diesase.

approved_indications aBLA / 505(b)(2) Activity


aBLA / 505(b)(2) Approved by FDA

Mvasi: Amgen/Allergan (September-2017)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Mvasi (Amgen/Allergan) (January-2018)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

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 Appeal Ongoing

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

Patent Owner
Genentech, Inc.

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y

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):

U.S. Patent Nos.
[None Listed]

Plaintiffs
Genentech, Inc.

Defendants
Amgen Inc.

Status
Dismissed

BPCIA
Y

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) 6,417,335 (Protein Purification) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 6,620,918 (Separation of Polypeptide Monomers) 6,870,034 (Protein Purification) 6,884,879 (Anti-VEGF Antibodies) 7,060,269 (Anti-VEGF Antibodies) 7,169,901 (Anti-VEGF Antibodies) 7,375,193 (Anti-VEGF Antibodies) 7,622,115 (Treatment With Anti-VEGF Antibodies) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 8,044,017 (Protein Purification) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 8,512,983 (Production of Proteins in Glutamine-Free Cell Culture Media) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,633,302 (Variable Tangential Flow Filtration) 8,710,196 (Protein Purification) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,795,672 (Treatment with Anti-VEGF Antibodies)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Amgen Inc.

Status
Case Ongoing; Consolidated with 1:17-cv-01471 (D. Del.)

BPCIA
Y

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) 6,417,335 (Protein Purification) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 6,620,918 (Separation of Polypeptide Monomers) 6,870,034 (Protein Purification) 6,884,879 (Anti-VEGF Antibodies) 7,060,269 (Anti-VEGF Antibodies) 7,169,901 (Anti-VEGF Antibodies) 7,297,334 (Anti-VEGF Antibodies) 7,375,193 (Anti-VEGF Antibodies) 7,622,115 (Treatment With Anti-VEGF Antibodies) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 8,044,017 (Protein Purification) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 8,512,983 (Production of Proteins in Glutamine-Free Cell Culture Media) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,633,302 (Variable Tangential Flow Filtration) 8,710,196 (Protein Purification) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,795,672 (Treatment with Anti-VEGF Antibodies)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Amgen Inc.

Status
Case Ongoing; Consolidated with Lead Case 1:17-cv-01407 (D. Del.)

BPCIA
Y

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) 6,417,335 (Protein Purification) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 6,870,034 (Protein Purification) 6,884,879 (Anti-VEGF Antibodies) 7,060,269 (Anti-VEGF Antibodies) 7,169,901 (Anti-VEGF Antibodies) 7,297,334 (Anti-VEGF Antibodies) 7,323,553 (Non-Affinity Purification of Proteins) 7,375,193 (Anti-VEGF Antibodies) 7,622,115 (Treatment With Anti-VEGF Antibodies) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 8,044,017 (Protein Purification) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 8,512,983 (Production of Proteins in Glutamine-Free Cell Culture Media) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,633,302 (Variable Tangential Flow Filtration) 8,710,196 (Protein Purification) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase)

Plaintiffs
Amgen Inc.

Defendants
Genentech, Inc.; City of Hope

Status
Dismissed

BPCIA
Y

U.S. Patent Nos.
5,849,522 (Enhancer for Eukaryotic Expression Systems) 6,218,140 (Enhancer for Eukaryotic Expression Systems)

Plaintiffs
Sanofi-Aventis Deutschland GmbH; Sanofi-Aventis U.S. LLC; Sanofi-Aventis U.S. Inc.

Defendants
Biogen IDEC, Inc.; Genentech, Inc.

Federal Circuit Appeal(s)
12-1454

Status
Case Terminated

BPCIA
N

U.S. Patent Nos.
5,849,522 (Enhancer for Eukaryotic Expression Systems) 6,218,140 (Enhancer for Eukaryotic Expression Systems)

Plaintiffs
Sanofi-Aventis Deutschland GmbH

Defendants
Biogen IDEC, Inc.; Genentech, Inc.

Federal Circuit Appeal(s)
12-1454

Status
Case Terminated

BPCIA
N

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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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