Bmab 1500 (pertuzumab)

Bmab 1500 Approval Pending

Bmab 1500 (pertuzumab)

Bmab 1500 Approval Pending

U.S. License Holder:

Biocon

Date of License:

Submission Date Undisclosed, Prior to January-2026

Last Update:

July-31-2026

approved_indications FDA-Approved Indications


Bmab 1500 (pertuzumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
8,652,474 (Composition Comprising Antibody that Binds to Domain II of HER2 and Acidic Variants Thereof) 9,181,346 (Composition Comprising Antibody that Binds to Domain II of HER2 and Acidic Variants Thereof) 9,815,904 (Pertuzumab Variants and Evaluation Thereof) 9,969,811 (Pertuzumab Variants and Evaluation Thereof) 10,689,457 (Treatment of Metastatic Breast Cancer) 10,808,037 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 10,822,404 (Methods and Compositions Comprising Purified Recombinant Polypeptides) 11,077,189 (Adjuvant Treatment of HER2-Positive Breast Cancer) 11,078,294 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 11,414,498 (Composition Comprising Antibody that Binds to Domain II of HER2 and Acidic Variants Thereof) 11,597,776 (Composition Comprising Antibody that Binds to Domain II of HER2 and Acidic Variants Thereof) 11,638,756 (Adjuvant Treatment of HER2-Positive Breast Cancer) 11,655,305 (Treatment of Metastatic Breast Cancer) 11,833,206 (Polysorbate Mixtures Having Modified Fatty Acid Ester Distribution) 11,992,529 (Adjuvant Treatment of HER2-Positive Breast Cancer) 12,103,975 (Production of Proteins in Glutamine-Free Cell Culture Media) 12,110,341 (Composition Comprising Antibody that Binds to Domain II of HER2 and Acidic Variants Thereof) 12,128,103 (Adjuvant Treatment of HER2-Positive Breast Cancer) 12,145,997 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 12,145,998 (Pertuzumab Variants and Evaluation Thereof) 12,173,080 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 12,286,619 (Modulating Lactogenic Activity in Mammalian Cells) 12,351,641 (Production of Proteins in Glutamine-Free Cell Culture Media) 12,371,728 (Methods of Protein Production) 12,427,193 (Subcutaneous Anti-HER2 Antibody Formulations and Uses Thereof) 12,479,883 (Methods of Reducing the Enzymatic Hydrolysis Activity Rate in a Composition Obtained from a Purification Platform) 12,527,867 (Uses for and Article of Manufacture Including HER2 Dimerization Inhibitor Pertuzumab)

Plaintiffs
Genentech, Inc.

Defendants
Biocon Biologics Inc.; Biocon Biologics Germany GMBH; Biocon Biologics Limited; Biocon Biologics UK Limited

Status
Complaint Withdrawn

BPCIA
Y

U.S. Patent Nos.
8,652,474 (Composition Comprising Antibody that Binds to Domain II of HER2 and Acidic Variants Thereof) 11,597,776 (Composition Comprising Antibody that Binds to Domain II of HER2 and Acidic Variants Thereof) 12,145,997 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 12,173,080 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides)

Plaintiffs
Genentech, Inc.

Defendants
Biocon Biologics Inc.; Biocon Biologics International Ltd.; Biocon Biologics Limited; Biocon Biologics UK PLC; Biocon Limited

Status
Complaint Withdrawn

BPCIA
N

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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