The U.S. Food and Drug Administration has approved two denosumab biosimilars from Accord BioPharma, Inc., expanding treatment options for patients with bone-related disorders and cancer complications. OSVYRTI (denosumab-desu), a biosimilar to Amgen's Prolia, and JUBEREQ (denosumab-desu), a biosimilar to Xgeva, represent the company's fourth and fifth biosimilar approvals, demonstrating significant growth in the competitive biosimilar market.
Comprehensive Indication Coverage
OSVYRTI received approval for all indications of its reference product Prolia, including treatment of postmenopausal women with osteoporosis at high risk for fracture, increasing bone mass in men with osteoporosis at high risk for fracture, and treating glucocorticoid-induced osteoporosis in both men and women at high risk for fracture. The biosimilar is also indicated to increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer and women receiving adjuvant aromatase inhibitor therapy for breast cancer.
JUBEREQ similarly gained approval for all Xgeva indications, including prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with unresectable giant cell tumor of bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Clinical Evidence Supporting Approval
The FDA approval was based on results from two pivotal trials that met their primary endpoints. A Phase I randomized, double-blind, three-arm pharmacokinetic study compared JUBEREQ to Xgeva in healthy adult males, demonstrating comparable PK parameters between the two products. The Phase III study was a randomized, double-blind, active-controlled, parallel arm, multicenter trial comparing pharmacokinetics, pharmacodynamics, efficacy and safety of OSVYRTI to Prolia in postmenopausal women with osteoporosis.
According to the clinical study results, OSVYRTI and its reference product Prolia are highly similar, with no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety and efficacy. These findings support the biosimilar designation and provide confidence in therapeutic equivalence.
Market Impact and Commercial Strategy
The approvals target a substantial market opportunity, as global Prolia sales increased 8% year over year to more than $4.374 billion in 2024, while Xgeva revenues climbed 5% to $2.225 billion, placing both products among Amgen's top five highest-selling drugs. Accord BioPharma is currently working to commercialize both biosimilars with a planned marketplace launch in 2026.
"Both OSVYRTI and JUBEREQ have been approved for a wide variety of bone-related indications, including osteoporosis and bone loss from the treatment of certain kinds of cancer," said Chrys Kokino, President, Accord North America. "These biosimilars have the potential to provide a large number of patients with treatment alternatives that lessen cost as a barrier to accessing proven therapies."
Manufacturing and Development Milestone
The approvals represent a significant milestone for Accord BioPharma's internal capabilities. "OSVYRTI and JUBEREQ are the first biosimilars Accord has developed completely on its own, and we will manufacture these products internally without a third-party partnership," said Mr. Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "We believe biosimilars are here to stay, and we are investing in their promise of cost savings for patients and the entire U.S. healthcare system."
Safety Profile and Monitoring Requirements
Both biosimilars carry important safety warnings consistent with their reference products. OSVYRTI includes a Boxed Warning for severe hypocalcemia in patients with advanced kidney disease and is approved with a Risk Evaluation and Mitigation Strategy (REMS) program. Key safety considerations include risks of osteonecrosis of the jaw, atypical femoral fractures, and multiple vertebral fractures following treatment discontinuation.
JUBEREQ carries warnings for hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, and embryo-fetal toxicity. Both products require careful patient monitoring and appropriate calcium and vitamin D supplementation.
Expanding Biosimilar Portfolio
The dual approvals strengthen Accord BioPharma's growing biosimilar portfolio, which has experienced significant expansion over the past year. The company currently markets UDENYCA (pegfilgrastim-cbqv), IMULDOSA (ustekinumab-srlf), HERCESSI (trastuzumab-strf), and CAMCEVI (leuprolide), with additional pipeline products including a golimumab biosimilar candidate through an exclusive agreement with Bio-Thera Solutions.
