Perjeta® (pertuzumab)

BL 125409

Perjeta® (pertuzumab)

BL 125409

U.S. License Holder:

Genentech

Date of License:

June-08-2012

Last Update:

Aug-15-2025

approved_indications FDA-Approved Indications

PERJETA (pertuzumab) is a HER2/neu receptor antagonist indicated for:

Use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease;

Use in combination with trastuzumab and chemotherapy as: neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

approved_indications aBLA / 505(b)(2) Activity

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

HLX11: Shanghai Henlius Biotech / Organon (February-2025)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:22-cv-00145 (D. Del.)

U.S. Patent Nos.
7,625,558 (Compositions and Methods of Treating Tumors)

Plaintiffs
Trustees of The University of Pennsylvania

Defendants
Genentech, Inc.

Status
Summary Judgment of Invalidity of Claims 8, 13, 35, 55, 60, 68, 74, 79, 81, 84, and 86 of U.S. Patent No. 7,625,558; Stipulated Dismissal due to Settlement

BPCIA
N

2:25-cv-14648 (D.N.J.)

U.S. Patent Nos.
7,449,184 (Fixed Dosing of HER Antibodies) 7,862,817 (Humanized Anit-ERBB2 Antibodies and Treatment with Anti-ERBB2 Antibodies) 8,404,234 (Fixed Dosing of HER Antibodies) 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) 10,662,237 (Method to Improve Virus Filtration Capacity) 10,676,710 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,689,457 (Treatment of Metastatic Breast Cancer) 10,808,037 (Prevention of Disulfide Bond Reduction During Recombinant Production of 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) 11,992,529 (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)

Plaintiffs
Genentech, Inc.; Hoffmann-La Roche, Inc.

Defendants
Shanghai Henlius Biotech, Inc.; Shanghai Henlius Biologics Co. Ltd.; Organon & Co.; Organon LLC

Status
Case Ongoing

BPCIA
Y

Related News

Genentech Files First BPCIA Litigation Against Perjeta® (pertuzumab) Biosimilar Applicant
Robert S. Schwartz, Ph.D.
August 21, 2025
Venable’s BiologicsHQ Monthly Injection – March 2025
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
April 11, 2025
Shanghai Henlius Biotech’s aBLA for Perjeta® Biosimilar HLX11 Accepted by FDA
Robert S. Schwartz, Ph.D.
February 5, 2025

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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