Accord BioPharma specialty division of Intas Pharmaceuticals Announces FDA Approval of Denosumab Biosimilars OSVYRTI® and JUBEREQ®
Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals focused on oncology, immunology, and critical care therapies, has announced U.S. Food and Drug Administration (FDA) approval of OSVYRTI® (denosumab-desu), a biosimilar to Prolia®, and JUBEREQ® (denosumab-desu), a biosimilar to Xgeva®.
These dual approvals represent the company’s fourth and fifth biosimilars in the U.S. market.
OSVYRTI®: Biosimilar to Prolia®
OSVYRTI has been approved for all the same indications as its reference product, including:
- Treatment of postmenopausal women with osteoporosis at high risk for fracture
- Increasing bone mass in men with osteoporosis at high risk for fracture
- Treatment of glucocorticoid-induced osteoporosis in men and women
- Increasing bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Increasing bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer
Boxed Warning: Severe hypocalcemia in patients with advanced kidney disease.
OSVYRTI is also approved with a REMS program.
JUBEREQ®: Biosimilar to Xgeva®
JUBEREQ is approved for all indications of Xgeva, including:
- Prevention of skeletal-related events in patients with multiple myeloma
- Prevention of skeletal-related events in patients with bone metastases from solid tumors
- Treatment of adults and skeletally mature adolescents with unresectable giant cell tumor of bone
- Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy
Industry Impact
“These biosimilars have the potential to provide a large number of patients with treatment alternatives that lessen cost as a barrier,”
— Chrys Kokino, President, Accord North America
Prolia generated $4.374 billion globally in 2024, and Xgeva generated $2.225 billion, placing both among Amgen’s top five highest-selling drugs.
Clinical Trials Supporting Approval
The approvals were based on:
Phase I Trial
- Randomized, double-blind, three-arm PK study comparing JUBEREQ to Xgeva
- Conducted in healthy adult males
- Demonstrated comparable PK parameters
Phase III Trial
- Randomized, double-blind, active-controlled, multicenter study
- Compared OSVYRTI to Prolia in postmenopausal women with osteoporosis
- Demonstrated high similarity with no clinically meaningful differences in PK, PD, efficacy, or safety
Accord plans to commercialize both biosimilars in 2026.
Company Statements
“OSVYRTI and JUBEREQ are the first biosimilars developed completely in-house. We believe biosimilars are here to stay and will drive cost savings for patients and the U.S. healthcare system.”
— Mr. Binish Chudgar, Chairman and Managing Director, Intas Pharmaceuticals
Accord BioPharma’s U.S. portfolio has rapidly expanded, including:
- UDENYCA® franchise (all formats)
- IMULDOSA® (ustekinumab-srlf) – biosimilar to Stelara
- HERCESSI™ (trastuzumab-strf) – biosimilar to Herceptin
- CAMCEVI® (leuprolide) 42 mg injectable emulsion
Intas also has an exclusive agreement with Bio-Thera Solutions to bring BAT2506 (golimumab biosimilar to Simponi®) to the U.S.
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