Osvyrti® / Jubereq® (denosumab-desu)

aBL 761424

Osvyrti® / Jubereq® (denosumab-desu)

aBL 761424

U.S. License Holder:

Accord BioPharma / Intas

Date of License:

October-29-2025

Last Update:

June-08-2026

approved_indications FDA-Approved Indications

OSVYRTI (denosumab-desu) 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.

JUBEREQ (denosumab-desu) is a RANK ligand (RANKL) inhibitor indicated for:

Prevention of skeletal-related events in patients with multiple myeloma and in patients 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 The E.U.

Denosumab Intas (Intas) (November-2025)
Osvyrti® / Jubereq® (Accord) (May-2025)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:25-cv-01305 (D.N.J.) (transferred from 5:24-cv-00642 (E.D.N.C.)) / MDL 1:25-md-03138 (D.N.J.)

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
Consent Judgment and Injunction through 10/1/2025

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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