Truxima® (rituximab-abbs)

aBL 761088

Truxima® (rituximab-abbs)

aBL 761088

U.S. License Holder:

Celltrion / Teva

Date of License:

November-28-2018

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of:

Adult patients with Non-Hodgkin's Lymphoma (NHL): Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent; Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens;

Adult Patients with Chronic Lymphocytic Leukemia (CLL): Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC);

Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies;

Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Truxima® (Teva) (April-2019)

Biosimilars Approved In The E.U.

Truxima® (Celltrion) (February-2017)

Biosimilars Approved In Australia

Truxima® / Ritemvia® / Rituzena® / Tuxella® (Celltrion) (April-2018)

Biosimilars Approved In South Korea

Truxima® (CT P10) (Celltrion) (November-2016)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2015-01733

U.S. Patent No.
7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor)

Patent Owner
Genentech, Inc.

Petitioner(s)
Celltrion, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-14

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Petitioner Requested Dismissal Prior to Institution Decision)

IPR Status
IPR Terminated Prior to Institution Decision (Petitioner Requested Dismissal Without Prejudice)

IPR2015-01744

U.S. Patent No.
7,820,161 (Treatment of Autoimmune Diseases)

Patent Owner
Biogen Inc.; Biogen IDEC, Inc.; Genentech, Inc.

Petitioner(s)
Celltrion, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 2, 5, 6, 9, 10

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Petitioner Requested Dismissal Prior to Institution Decision)

IPR Status
IPR Terminated Prior to Institution Decision (Petitioner Requested Dismissal Without Prejudice)

IPR2016-01614

U.S. Patent No.
7,820,161 (Treatment of Autoimmune Diseases)

Patent Owner
Biogen Inc.; Genentech, Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH f/k/a Ivax International GmbH

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-12

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
18-1885; 18-1924 (consolidated with 18-1885)

IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal 18-1924 Dismissed; Federal Circuit Appeal 18-1885 Voluntarily Dismissed

IPR2016-01667

U.S. Patent No.
7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor)

Patent Owner
Genentech, Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH f/k/a Ivax International GmbH

§ 102 Challenge
Y: Claims 1-5, 7-14

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-14

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

IPR2017-01093

U.S. Patent No.
8,329,172 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody)

Patent Owner
Biogen Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH

§ 102 Challenge
Y: Claim 1

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claim 1

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2017-01094

U.S. Patent No.
8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody)

Patent Owner
Biogen Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-2

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Petitioner Request for Rehearing of Institution Decision Denied

IPR2017-01095

U.S. Patent No.
9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies)

Patent Owner
Biogen Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH

§ 102 Challenge
Y: Claims 1-6

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-6

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1253

IPR Status
Petitioner Request for Rehearing of Institution Decision Denied; Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Terminated as to Celltrion Due to Settlement, Voluntarily Dismissed as to US as Intervenor

IPR2017-01227

U.S. Patent No.
7,682,612 (Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody)

Patent Owner
Biogen Inc.; Genentech, Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH

§ 102 Challenge
N

§ 103 challenge
Y: Claims 23-35, 37-57

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2017-01229

U.S. Patent No.
8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies)

Patent Owner
Biogen Inc.; Genentech, Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH

§ 102 Challenge
Y: Claims 1, 5, 7-9

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-9

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2017-01230

U.S. Patent No.
7,682,612 (Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody)

Patent Owner
Biogen Inc.; Genentech, Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH

§ 102 Challenge
Y: Claims 1-7, 11-13, 15-18, 21-22, 59-60

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-13, 15-22, 58-60

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2018-01019

U.S. Patent No.
7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor)

Patent Owner
Genentech, Inc.

Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-14

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y; Joined with IPR2017-01923

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Joined with IPR2017-01923; Terminated After Institution Due to Settlement

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:18-cv-00574 (D.N.J.)

U.S. Patent Nos.
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) 6,417,335 (Protein Purification) 6,455,043 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 6,489,447 (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) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,381,560 (Expression and Use of Anti-CD20 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,682,612 (Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,820,161 (Treatment of Autoimmune Diseases) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,044,017 (Protein Purification) 8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies) 8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 8,357,301 (Chromatography Equipment Characterization) 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) 8,545,843 (Treatment of Vasculitis) 8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody) 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) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies) 9,428,548 (Enhanced Protein Purification Through a Modified Protein A Elution) 9,428,766 (Protein Expression from Multiple Nucleic Acids) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)

Plaintiffs
Biogen, Inc.; City of Hope; Genentech, Inc.; Hoffmann-La Roche Inc.

Defendants
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.

Status
Settled

BPCIA
Y

1:18-cv-11553 (D.N.J.)

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,489,447 (Protein Purification) 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 7,381,560 (Expression and Use of Anti-CD20 Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,820,161 (Treatment of Autoimmune Diseases) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies) 8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 8,545,843 (Treatment of Vasculitis) 8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody) 9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies) 9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody)

Plaintiffs
Biogen, Inc.; City of Hope; Genentech, Inc.; Hoffmann-La Roche Inc.

Defendants
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.

Status
Settled

BPCIA
Y

4:18-cv-00276 (N.D. Cal.)

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,417,335 (Protein Purification) 6,455,043 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 6,489,447 (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) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,682,612 (Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,820,161 (Treatment of Autoimmune Diseases) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,044,017 (Protein Purification) 8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies) 8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 8,357,301 (Chromatography Equipment Characterization) 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) 8,545,843 (Treatment of Vasculitis) 8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody) 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) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies) 9,428,548 (Enhanced Protein Purification Through a Modified Protein A Elution) 9,428,766 (Protein Expression from Multiple Nucleic Acids) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)

Plaintiffs
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.

Defendants
Biogen, Inc.; City of Hope; Genentech, Inc.; Hoffmann-La Roche Inc.

Federal Circuit Appeal(s)
18-2161 (Consolidated with 18-2160; 18-2160 is Lead Appeal)

Status
Dismissed for Failure to State a Claim; Federal Circuit Appeal Voluntarily Dismissed

BPCIA
Y

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September 9, 2019
Venable’s BiologicsHQ Monthly Injection – July 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
August 6, 2019
Venable’s BiologicsHQ Monthly Injection – May 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
June 6, 2019
Venable’s BiologicsHQ Monthly Injection – April 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
May 7, 2019
Venable’s BiologicsHQ Monthly Injection – March 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
April 5, 2019
Venable’s BiologicsHQ Monthly Injection – February 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
March 6, 2019
Venable’s BiologicsHQ Monthly Injection – January 2019
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
February 11, 2019
Venable’s BiologicsHQ Monthly Injection – December 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
January 9, 2019
Venable’s BiologicsHQ Monthly Injection – November 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
December 11, 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 – April 2018
April M. Breyer Menon Corinne E. Atton Joseph K. Yarsky Robert S. Schwartz, Ph.D.
May 3, 2018

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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