Prolia® / Xgeva® (denosumab)

BL 125320

Prolia® / Xgeva® (denosumab)

BL 125320

U.S. License Holder:

Amgen

Date of License:

June-01-2010

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

PROLIA (denosumab) is a RANK ligand (RANKL) inhibitor indicated for treatment:

Of postmenopausal women with osteoporosis at high risk for fracture;

To increase bone mass in men with osteoporosis at high risk for fracture;

Of glucocorticoid-induced osteoporosis in men and women at high risk for fracture;

To increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer;

To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

XGEVA (denosumab) is a RANK ligand (RANKL) inhibitor indicated for:

Prevention of skeletal-related events in patients with multiple myeloma and in pateients with bone metastases from solid tumors;

Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity;

Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

approved_indications aBLA / 505(b)(2) Activity

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

Jubbonti® / Wyost®: Sandoz (March-2024, Interchangeable)

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

CT-P41: Celltrion (November-2023) FKS518: Fresenius Kabi (May-2024) SB16: Samsung Bioepis (Undisclosed Filing Date Prior to August-2024) TVB-009P (Teva) (October-2024) HLX14 (Organon / Shanghai Henlius Biotech) (October-2024) INTP23 (Accord / Intas) (Undisclosed Filing Date Prior to November-2024) RGB-14 (Gedeon Richter / Hikma) (December-2024)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Jubbonti® / Wyost® (Sandoz) (February-2024)

Biosimilars Approved In The E.U.

Jubbonti® / Wyost® (Sandoz) (May-2024)

Biosimilars Approved In South Korea

Stoboclo® / Osenvelt® (Celltrion) (November-2024)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:23-cv-02406 (D.N.J.)

U.S. Patent Nos.
7,364,736 (Antibodies to OPGL) 7,928,205 (Methods for Refolding of Recombinant Antibodies) 8,058,418 (Polynucleotides Encoding Heavy and Light Chains of Antibodies to OPGL) 9,012,178 (Dipeptides to Enhance Yield and Viability from Cell Cultures) 9,133,493 (Method for Culturing Mammalian Cells to Improve Recombinant Protein Production) 9,228,168 (Feed Media) 9,320,816 (Methods of Treating Cell Culture Media for Use in Bioreactor) 9,328,134 (Carbohydrate Phosphonate Derivatives as Modulators of Glycosylation) 9,359,435 (Methods for Modulating Mannose Content of Recombinant Proteins) 9,481,901 (Methods for Increasing Mannose Content of Recombinant Proteins) 10,167,492 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,513,723 (Decreasing Ornithine Production to Decrease High Mannose Glycoform Content of Recombinant Proteins) 10,583,397 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 10,822,630 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,894,972 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,077,404 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 11,098,079 (Charged Depth Filtration of Antigen-Binding Proteins) 11,130,980 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,254,963 (Increasing Ornithine Accumulation to Increase High Mannose Glycoform Content of Recombinant Proteins) 11,299,760 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,434,514 (Methods for Increasing Mannose Content of Recombinant Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing Limited

Defendants
Sandoz Inc.; Sandoz GmbH; Novartis AG; Novartis Pharmaceuticals Production D.o.o.; Lek Pharmaeuticals dd

Status
Settled; Stipulated Injunction Until February 19, 2025

BPCIA
Y

1:24-cv-06497 (D.N.J.)

U.S. Patent Nos.
7,364,736 (Antibodies to OPGL) 7,427,659 (Process for Purifying Proteins in a Hydrophobic Interaction Chromatography Flow-through Fraction) 7,928,205 (Methods for Refolding of Recombinant Antibodies) 8,053,236 (Feed Media) 8,460,896 (Host Cells and Culture Methods) 8,680,248 (Host Cells Comprising Alpha 1, 2 Mannosidase and Culture Methods Thereof) 9,012,178 (Dipeptides to Enhance Yield and Viability from Cell Cultures) 9,228,168 (Feed Media) 9,320,816 (Methods of Treating Cell Culture Media for Use in Bioreactor) 9,328,134 (Carbohydrate Phosphonate Derivatives as Modulators of Glycosylation) 9,359,435 (Methods for Modulating Mannose Content of Recombinant Proteins) 10,106,829 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,167,492 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,227,627 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,513,723 (Decreasing Ornithine Production to Decrease High Mannose Glycoform Content of Recombinant Proteins) 10,583,397 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 10,822,630 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,894,972 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,077,404 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 11,098,079 (Charged Depth Filtration of Antigen-Binding Proteins) 11,130,980 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,254,963 (Increasing Ornithine Accumulation to Increase High Mannose Glycoform Content of Recombinant Proteins) 11,299,760 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,319,568 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,434,514 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,459,595 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,486,883 (Method for Using Light Scattering in Real Time to Directly Monitor and Control Impurity Removal in Purification Processes) 11,946,085 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,952,605 (Methods for Increasing Mannose Content of Recombinant Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing Limited

Defendants
Celltrion, Inc.; Celltrion USA, Inc.

Status
Case Ongoing

BPCIA
Y

1:24-cv-08417 (D.N.J.)

U.S. Patent Nos.
7,364,736 (Antibodies to OPGL) 7,888,101 (Host Cells Comprising Alpha 1, 2 Mannosidase and Culture Methods Thereof) 7,928,205 (Methods for Refolding of Recombinant Antibodies) 8,058,418 (Polynucleotides Encoding Heavy and Light Chains of Antibodies to OPGL) 8,247,210 (Host Cells Comprising Alpha 1,2 Mannosidase and Culture Methods Thereof) 8,460,896 (Host Cells and Culture Methods) 8,680,248 (Host Cells Comprising Alpha 1, 2 Mannosidase and Culture Methods Thereof) 9,012,178 (Dipeptides to Enhance Yield and Viability from Cell Cultures) 9,320,816 (Methods of Treating Cell Culture Media for Use in Bioreactor) 9,328,134 (Carbohydrate Phosphonate Derivatives as Modulators of Glycosylation) 9,359,435 (Methods for Modulating Mannose Content of Recombinant Proteins) 9,481,901 (Methods for Increasing Mannose Content of Recombinant Proteins) 10,106,829 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,167,492 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,227,627 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,421,987 (Methods for Increasing Mannose Content of Recombinant Proteins) 10,513,723 (Decreasing Ornithine Production to Decrease High Mannose Glycoform Content of Recombinant Proteins) 10,583,397 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 10,655,156 (Overexpression of N-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,822,630 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,894,972 (Methods for Increasing Mannose Content of Recombinant Proteins) 10,907,186 (Overexpression of N-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 11,098,079 (Charged Depth Filtration of Antigen-Binding Proteins) 11,130,980 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,254,963 (Increasing Ornithine Accumulation to Increase High Mannose Glycoform Content of Recombinant Proteins) 11,292,829 (Mammalian Cell Culture) 11,299,760 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,384,378 (Methods for Harvesting Mammalian Cell Cultures) 11,427,848 (Methods for Harvesting Mammalian Cell Cultures) 11,434,514 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,634,476 (Mammalian Cell Culture) 11,685,772 (Mammalian Cell Culture) 11,744,950 (Controlled Dispense Syringe) 11,946,085 (Methods for Increasing Mannose Content of Recombinant Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing Limited

Defendants
Samsung Bioepis Co. Ltd.; Samsung BioLogics Co. Ltd.

Status
Case Ongoing

BPCIA
Y

1:24-cv-09555 (N.D. Ill.)

U.S. Patent Nos.
7,364,736 (Antibodies to OPGL) 7,888,101 (Host Cells Comprising Alpha 1, 2 Mannosidase and Culture Methods Thereof) 7,928,205 (Methods for Refolding of Recombinant Antibodies) 8,053,236 (Feed Media) 8,058,418 (Polynucleotides Encoding Heavy and Light Chains of Antibodies to OPGL) 8,460,896 (Host Cells and Culture Methods) 8,680,248 (Host Cells Comprising Alpha 1, 2 Mannosidase and Culture Methods Thereof) 9,012,178 (Dipeptides to Enhance Yield and Viability from Cell Cultures) 9,228,168 (Feed Media) 9,320,816 (Methods of Treating Cell Culture Media for Use in Bioreactor) 9,328,134 (Carbohydrate Phosphonate Derivatives as Modulators of Glycosylation) 9,359,435 (Methods for Modulating Mannose Content of Recombinant Proteins) 10,106,829 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,167,492 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,227,627 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,513,723 (Decreasing Ornithine Production to Decrease High Mannose Glycoform Content of Recombinant Proteins) 10,583,397 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 10,655,156 (Overexpression of N-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,822,630 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,894,972 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,077,404 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 11,098,079 (Charged Depth Filtration of Antigen-Binding Proteins) 11,130,980 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,254,963 (Increasing Ornithine Accumulation to Increase High Mannose Glycoform Content of Recombinant Proteins) 11,299,760 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,319,568 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,434,514 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,459,595 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,744,950 (Controlled Dispense Syringe) 11,786,866 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 11,946,085 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,952,605 (Methods for Increasing Mannose Content of Recombinant Proteins) 12,084,686 (Antibodies with Modulated Glycan Profiles)

Plaintiffs
Amgen Inc.; Amgen Manufacturing Limited

Defendants
Fresenius Kabi USA, LLC; Fresenius Kabi Austria GmbH; Fresenius Kabi Deutschland GmbH; Fresenius Kabi SwissBioSim GmbH

Status
Case Ongoing

BPCIA
Y

5:24-cv-00642 (E.D.N.C.)

U.S. Patent Nos.
7,364,736 (Antibodies to OPGL) 7,662,930 (Polishing Steps Used in Multi-step Protein Purification Processes) 7,888,101 (Host Cells Comprising Alpha 1, 2 Mannosidase and Culture Methods Thereof) 7,928,205 (Methods for Refolding of Recombinant Antibodies) 8,053,236 (Feed Media) 8,058,418 (Polynucleotides Encoding Heavy and Light Chains of Antibodies to OPGL) 8,460,896 (Host Cells and Culture Methods) 8,680,248 (Host Cells Comprising Alpha 1, 2 Mannosidase and Culture Methods Thereof) 9,012,178 (Dipeptides to Enhance Yield and Viability from Cell Cultures) 9,133,493 (Method for Culturing Mammalian Cells to Improve Recombinant Protein Production) 9,228,168 (Feed Media) 9,320,816 (Methods of Treating Cell Culture Media for Use in Bioreactor) 9,328,134 (Carbohydrate Phosphonate Derivatives as Modulators of Glycosylation) 9,359,435 (Methods for Modulating Mannose Content of Recombinant Proteins) 9,388,447 (Method for Culturing Mammalian Cells to Improve Recombinant Protein Production) 10,106,829 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,167,492 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,227,627 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,513,723 (Decreasing Ornithine Production to Decrease High Mannose Glycoform Content of Recombinant Proteins) 10,583,397 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 10,655,156 (Overexpression of N-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,822,630 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,894,972 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,077,404 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 11,098,079 (Charged Depth Filtration of Antigen-Binding Proteins) 11,130,980 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,254,963 (Increasing Ornithine Accumulation to Increase High Mannose Glycoform Content of Recombinant Proteins) 11,299,760 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,319,568 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,434,514 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,459,595 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,946,085 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,952,605 (Methods for Increasing Mannose Content of Recombinant Proteins) 12,084,686 (Antibodies with Modulated Glycan Profiles)

Plaintiffs
Amgen Inc.; Amgen Manufacturing Limited

Defendants
Accord BioPharma, Inc.; Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.

Status
Case Ongoing

BPCIA
Y

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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