Kanjinti® (trastuzumab-anns)

aBL 761073

Kanjinti® (trastuzumab-anns)

aBL 761073

U.S. License Holder:

Amgen / Allergan

Date of License:


Last Update:


approved_indications FDA-Approved Indications

KANJINTI (trastuzumab-anns) is a HER2/neu receptor antagonist indicated for:

The treatment of HER2-overexpressing breast cancer;

The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Kanjinti® (Amgen) (February-2020)

Biosimilars Approved In The E.U.

Kanjinti® (Amgen / Allergan) (May-2018)

Biosimilars Approved In Australia

Kanjinti® (Amgen) (May-2019)

approved_indications U.S. Patent Litigations


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) 6,407,213 (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 6,620,918 (Separation of Polypeptide Monomers) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,870,034 (Protein Purification) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,449,184 (Fixed Dosing of HER Antibodies) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 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) 8,044,017 (Protein Purification) 8,076,066 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 8,314,225 (Heavy Chain Mutant Leading to Improved Immunoglobulin Production) 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) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,710,196 (Protein Purification) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,249,218 (Protein Purification) 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) 9,493,744 (Methods for Viral Inactivation and Other Adventitious Agents) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media) 9,868,760 (Protein Purification) 10,160,811 (Treatment with Anti-ErbB2 Antibodies)

City of Hope; Genentech, Inc.

Amgen Inc.

Federal Circuit Appeal(s)
19-2156 (TRO and PI)

Federal Circuit Affirmed Denial of of Temporary Restraining Order and Preliminary Injunction; Stipulated Dismissal Due to Settlement



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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