Mvasi® (bevacizumab-awwb)

aBL 761028

Mvasi® (bevacizumab-awwb)

aBL 761028

U.S. License Holder:

Amgen / Allergan

Date of License:

September-14-2017

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

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

Metastatic colorectal cancer, in combination with intravenous 5-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 Mvasi 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 Mvasi as a single agent, for platinum-sensitive recurrent disease.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Mvasi® (Amgen) (October-2018)

Biosimilars Approved In The E.U.

Mvasi® (Amgen/Allergan) (January-2018)

Biosimilars Approved In Australia

Mvasi® (Amgen) (June-2020)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:17-cv-00165 (D. Del.)

U.S. Patent Nos.
[None Listed]

Plaintiffs
Genentech, Inc.

Defendants
Amgen Inc.

Status
Dismissed

BPCIA
Y

1:17-cv-01407 (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) 6,417,335 (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) 7,323,553 (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) 9,795,672 (Treatment with Anti-VEGF Antibodies)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Amgen Inc.

Status
Consolidated with 1:17-cv-01471 (D. Del.); Stipulated Dismissal Due to Settlement

BPCIA
Y

1:17-cv-01471 (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) 6,417,335 (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) 9,795,672 (Treatment with Anti-VEGF Antibodies)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Amgen Inc.

Status
Consolidated with Lead Case 1:17-cv-01407 (D. Del.); Stipulated Dismissal Due to Settlement

BPCIA
Y

1:19-cv-00602 (D. Del.)

U.S. Patent Nos.
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) 6,620,918 (Separation of Polypeptide Monomers) 7,060,269 (Anti-VEGF Antibodies) 7,169,901 (Anti-VEGF Antibodies) 7,622,115 (Treatment With Anti-VEGF Antibodies) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 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) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,493,744 (Methods for Viral Inactivation and Other Adventitious Agents) 9,714,293 (Production of Proteins in Glutamine-Free Cell Culture Media) 9,795,672 (Treatment with Anti-VEGF Antibodies)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Amgen Inc.; Immunex Rhode Island Corp.

Federal Circuit Appeal(s)
19-2155

Status
Federal Circuit Appeal of Denials of Temporary Restraining Order and Motion to Enforce Statutory Prohibition on Commercial Marketing Affirmed; Stipulated Dismissal Due to Settlement

BPCIA
Y

2:17-cv-07349 (C.D. Cal.)

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

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Methodology

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