Jubbonti® / Wyost® (denosumab-bbdz)

aBL 761362

Jubbonti® / Wyost® (denosumab-bbdz)

aBL 761362

U.S. License Holder:

Sandoz Inc.

Date of License:

March-05-2024 (Interchangeable)

Last Update:

Apr-08-2024

approved_indications FDA-Approved Indications


JUBBONTI (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor indicated for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture;

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

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

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

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

WYOST (denosumab-bbdz) 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 Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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
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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