Avastin® (bevacizumab)

BL 125085

Avastin® (bevacizumab)

BL 125085

U.S. License Holder:

Genentech

Date of License:

February-26-2004

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

AVASTIN (bevacizumab) 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 product-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;

Hepatocellular Carcinoma (HCC): In combination with atezolizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.

approved_indications aBLA / 505(b)(2) Activity

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

Mvasi®: Amgen/Allergan (September-2017) Zirabev®: Pfizer (June-2019) Alymsys®: Amneal / mAbxience (April-2022) Vegzelma®: Celltrion (September-2022) Avzivi®: Bio-Thera Solutions (December-2023)

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

SB8: Samsung Bioepis (November-2019) FKB238: Centus / Fujifilm Kyowa Kirin (November-2019) MYL-1402O: Mylan/Biocon (March-2020; Complete Response Letter February-2023)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Abevmy (Biocon / Viatris) (November-2021)
Aybintio (Samsung Bioepis) (November-2021)
Bambevi® (Apobiologix) (September-2021)
Mvasi® (Amgen) (October-2018)
Vegzelma® (Celltrion) (January-2023)
Zirabev® (Pfizer) (June-2019)

Biosimilars Approved In The E.U.

Abevmy (Biocon / Viatris) (April-2021)
Alymsys® (mAbxience) (March-2021)
Avzivi® (Bio-Thera Solutions) (July-2024)
Aybintio (Samsung Bioepis) (August-2020)
Equidacent (Centus Biotherapeutics) (September-2020)
Lytenava (for Wet AMD) (Outlook Therapeutics) (EU: May-2024, UK: July-2024)
Mvasi® (Amgen/Allergan) (January-2018)
Onbevzi® (Samsung Bioepis) (January-2021)
Oyavas (STADA) (March-2021)
Vegzelma® (Celltrion) (EU: August-2022, UK: September-2022)
Versavo® (Dr. Reddy's) (UK: Launched March-2024)
Zirabev® (Pfizer) (February-2019)

Biosimilars Approved In Australia

Abevmy® (Alphapharm) (September-2021)
Bevaciptin® / Bevacip® (Cipla) (November-2021) Vegzelma® (Celltrion) (September-2023)
Mvasi® (Amgen) (June-2020)
Onbevzi® (Samsung Bioepis) (January-2024)
Zirabev® (Pfizer) (November-2019)

Biosimilars Approved In Japan

Bevacizumab BS (Daiichi Sankyo) (September-2019)
Vegzelma® (Celltrion) (September-2022)

Biosimilars Approved In South Korea

Onbevzi® (Boryung Pharmaceutical / Samsung Bioepis) (September-2021)
Vegzelma® (Celltrion) (September-2022)

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):

1:17-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

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

1:20-cv-00859 (D. Del.)

U.S. Patent Nos.
6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO.sub.2 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) 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) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media) 9,795,672 (Treatment with Anti-VEGF Antibodies) 10,208,355 (Method of Treatment for Glioblastoma by Administering a VEGF Antagonist) 10,513,697 (CO.sub.2 Profile Cultivation) 10,662,237 (Method to Improve Virus Filtration Capacity) 10,676,710 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production)

Plaintiffs
Genentech, Inc.

Defendants
Samsung Bioepis Co., Ltd.

Status
Settled

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

2:20-cv-00361 (E.D. Tex.)

U.S. Patent Nos.
6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,795,672 (Treatment with Anti-VEGF Antibodies) 10,017,732 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,208,355 (Method of Treatment for Glioblastoma by Administering a VEGF Antagonist) 10,336,983 (Method for Increasing the Specific Production Rate of Eukaryotic Cells) 10,662,237 (Method to Improve Virus Filtration Capacity) 10,676,710 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production)

Plaintiffs
Genentech, Inc.

Defendants
Centus Biotherapeutics Limited; Fujifilm Corporation; Fujifilm Kyowa Kirin Biologics Co., Ltd.; Kyowa Kirin Co., Ltd.

Status
Settled

BPCIA
Y

3:08-cv-04909 (N.D. Cal.)

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

3:09-cv-04919 (N.D. Cal.)

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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April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
March 6, 2019
Venable’s BiologicsHQ Monthly Injection – August 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
September 6, 2018
Venable’s BiologicsHQ Monthly Injection – May 2018
April M. Breyer Menon Joseph K. Yarsky Corinne E. Atton Robert S. Schwartz, Ph.D.
June 8, 2018
Venable’s BiologicsHQ Monthly Injection – March 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
April 6, 2018
Venable’s BiologicsHQ Monthly Injection – February 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
March 6, 2018
Venable’s BiologicsHQ Monthly Injection – January 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
February 7, 2018
Venable’s BiologicsHQ Monthly Injection – December 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
January 8, 2018
Venable’s BiologicsHQ Monthly Injection – October 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
November 3, 2017

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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