Products will treat osteoporosis and skeletal-related events from certain types of bone cancer, expanding the company's biosimilar portfolio

Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced the U.S. Food and Drug Administration (FDA) approval of OSVYRTI^® (denosumab-desu), a biosimilar to Prolia^® (denosumab), and JUBEREQ^® (denosumab-desu), a biosimilar to Xgeva^® (denosumab). The dual approvals mark Accord BioPharma's fourth and fifth biosimilars, demonstrating the company's continued growth in the U.S. market.

Approved for all of the same indications of its reference product Prolia, developed by Amgen, OSVYRTI is 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, treatment 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, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. OSVYRTI carries a Boxed Warning for severe hypocalcemia in patients with advanced kidney disease. Like Prolia, OSVYRTI is approved with a REMS program.

JUBEREQ was also approved for all indications of its reference product (Xgeva, developed by Amgen).  JUBEREQ is indicated for the 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, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.²

"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. At Accord, we are passionate about leading biosimilar adoption, and OSVYRTI and JUBEREQ represent significant steps in our mission to make biosimilars more accessible."

In 2024, global Prolia sales increased 8% year over year to more than $4.374 billion, while Xgeva revenues climbed 5% to $2.225 billion, putting both products among Amgen's top five highest-selling drugs.

The approval of OSVYRTI and JUBEREQ is based on results from two trials: a Phase I trial and a Phase III trial that met their primary endpoints. The Phase I trial was a randomized, double-blind, three-arm pharmacokinetic (PK) study comparing JUBEREQ to Xgeva in healthy adult males. The study demonstrated that PK parameters were found to be comparable between the two products.⁴ The Phase III study was a randomized, double-blind, active-controlled, parallel arm, multicenter study comparing PK/PD, efficacy and safety of OSVYRTI to Prolia in postmenopausal women with osteoporosis. The clinical study results demonstrated that OSVYRTI and its reference product, Prolia, are highly similar, and have no clinically meaningful differences in terms of PK, PD, safety and efficacy.

Accord is currently working to commercialize OSVYRTI and JUBEREQ and bring these brands to the marketplace in 2026. More details will be provided closer to availability.

"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."

Accord BioPharma's portfolio has experienced sizable growth within the past year. The company assumed U.S. operations earlier this year for the full UDENYCA^® (pegfilgrastim-cbqv) franchise, including the UDENYCA pre-filled syringe, the UDENYCA autoinjector, and UDENYCA ONBODY^®. Accord BioPharma is also marketing IMULDOSA^® (ustekinumab-srlf), a biosimilar to Stelara^® (ustekinumab), HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin^® (trastuzumab), and CAMCEVI^® (leuprolide) 42 mg injectable emulsion. Please refer to the Important Safety Information and full Prescribing Information for all products, and to the Boxed Warning for HERCESSI.

Intas Pharmaceuticals, Ltd. has an exclusive agreement with Bio-Thera Solutions to enable Accord BioPharma to bring Bio-Thera's golimumab candidate BAT2506 – a biosimilar to Simponi^® (golimumab) – to the U.S. market.