Herzuma® (trastuzumab)

Herzuma® Approval Pending

Herzuma® (trastuzumab)

Herzuma® Approval Pending

U.S. License Holder:

Teva / Celltrion

Date of License:

aBLA submitted to FDA July-2017; Complete Response Letter April-2018; Resubmitted June-2018

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


Herzuma® (trastuzumab) is not FDA-approved. An aBLA has been submitted to the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Herzuma® (Celltrion) (February-2018)

Biosimilars Approved In Australia

Herzuma® (Celltrion) (August-2018)

Biosimilars Approved In Japan

CT-P6 (Celltrion / Nippon Kayaku) (August-2018)

Biosimilars Approved In South Korea

Herzuma® (CT-P6) (Celltrion) (January-2014)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
8,591,897 (Anti-ErbB2 Antibody Adjuvant Therapy)

Patent Owner
Genentech, Inc.

Petitioner(s)
Celltrion, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N/A

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N/A

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Patent Owner Requested Adverse Judgment and Claim Cancellation Before Institution Decision

IPR Status
IPR Terminated Prior to Institution Decision (Patent Owner Requested Adverse Judgment and Claim Cancellation)

U.S. Patent No.
7,846,441 (Treatment with Anti-ERBB2 Antibodies)

Patent Owner
Genentech, Inc.

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

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1267

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Pending

U.S. Patent No.
7,892,549 (Treatment with Anti-ERBB2 Antibodies)

Patent Owner
Genentech, Inc.

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

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1270

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Pending

U.S. Patent No.
6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies)

Patent Owner
Genentech, Inc.

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

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1258

IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Pending

U.S. Patent No.
7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies)

Patent Owner
Genentech, Inc.

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

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1259

IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Pending

U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)

Patent Owner
Genentech, Inc.

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

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

IPR Status
IPR Trial Ongoing

U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)

Patent Owner
Genentech, Inc.

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

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

IPR Status
Final Written Decision (Some Instituted Claims Unpatentable)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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) 6,339,142 (Protein Purification) 6,407,213 (Method for Making Humanized Antibodies) 6,417,335 (Protein Purification) 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) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,449,184 (Fixed Dosing of HER Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,846,441 (Treatment with Anti-ERBB2 Antibodies) 7,892,549 (Treatment with anti-ErbB2 antibodies) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,993,834 (Detection of ErbB2 Gene Amplification to Increase the Likelihood of the Effectiveness of ErbB2 Antibody Breast Cancer Therapy) 8,076,066 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 8,357,301 (Chromatography Equipment Characterization) 8,425,908 (Treatment with Anti-ErbB2 Antibodies) 8,440,402 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 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) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,249,218 (Protein Purification) 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) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)

Plaintiffs
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
Case Ongoing

BPCIA
Y

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) 6,339,142 (Protein Purification) 6,407,213 (Method for Making Humanized Antibodies) 6,417,335 (Protein Purification) 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) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,449,184 (Fixed Dosing of HER Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,846,441 (Treatment with Anti-ERBB2 Antibodies) 7,892,549 (Treatment with anti-ErbB2 antibodies) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,993,834 (Detection of ErbB2 Gene Amplification to Increase the Likelihood of the Effectiveness of ErbB2 Antibody Breast Cancer Therapy) 8,076,066 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 8,357,301 (Chromatography Equipment Characterization) 8,425,908 (Treatment with Anti-ErbB2 Antibodies) 8,440,402 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 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) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,249,218 (Protein Purification) 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) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)

Plaintiffs
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
Case Ongoing; Consolidated with lead case 1:18-cv-00095 (D. Del.)

BPCIA
Y

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,339,142 (Protein Purification) 6,407,213 (Method for Making Humanized Antibodies) 6,417,335 (Protein Purification) 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) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,449,184 (Fixed Dosing of HER Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,846,441 (Treatment with Anti-ERBB2 Antibodies) 7,892,549 (Treatment with anti-ErbB2 antibodies) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,993,834 (Detection of ErbB2 Gene Amplification to Increase the Likelihood of the Effectiveness of ErbB2 Antibody Breast Cancer Therapy) 8,076,066 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 8,357,301 (Chromatography Equipment Characterization) 8,425,908 (Treatment with Anti-ErbB2 Antibodies) 8,440,402 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 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) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,249,218 (Protein Purification) 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) 9,714,293 (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
City of Hope; Genentech, Inc.; Hoffmann-La Roche Inc.

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

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