Mvasi (bevacizumab-awwb)

aBL 761028

Mvasi (bevacizumab-awwb)

aBL 761028

U.S. License Holder:

Amgen / Allergan

Date of License:

September-14-2017

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


MVASI (bevacizumab-awwb) 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;

Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease;

Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy;

Metastatic renal cell carcinoma with interferon alfa;

Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Mvasi: Amgen/Allergan (January-2018)

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

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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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