Accord BioPharma, the US specialty division of Intas Pharmaceuticals, has announced the FDA approval of Osvyrti (denosumab-desu) and Jubereq (denosumab-desu), biosimilars to Amgen’s denosumab products Prolia and Xgeva, respectively.
The approvals mark Accord BioPharma’s fourth and fifth biosimilar approvals, underscoring the company’s growing footprint in the US biologics market.
Accord said the products will treat osteoporosis and skeletal-related events associated with certain types of bone cancer, the same conditions that their respective reference products are approved for.
Denosumab is a monoclonal antibody that helps prevent bone breakdown by inhibiting the RANKL protein, which is involved in the formation and activation of osteoclasts, cells that normally break down bone.
Related: Fresenius Gets FDA Nod for Denosumab Biosimilars, Reaches Patent Settlement with Amgen
Osvyrti is indicated for treating individuals at high risk for fracture (which include postmenopausal women with osteoporosis), increasing bone mass in men with osteoporosis and managing glucocorticoid-induced osteoporosis in both men and women. It is also approved to increase bone mass in men receiving androgen-deprivation therapy for nonmetastatic prostate cancer and in women undergoing adjuvant aromatase inhibitor therapy for breast cancer.
Jubereq was likewise approved for all the indications of its reference product Xgeva: to prevent skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors; to treat adults and skeletally mature adolescents with unresectable giant cell tumor of bone or cases where surgery would lead to severe morbidity; and to treat hypercalcemia of malignancy that does not respond to bisphosphonate therapy.
“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.”
These are the first biosimilars developed fully in-house by Accord, without third-party manufacturing partnerships.
Because biologic drugs like denosumab are typically expensive, biosimilars, which are highly similar (in safety, efficacy and structure) but often more affordable, can increase access to treatment for a broader population.
Clinical trials of both Osvyrti and Jubereq showed no clinically meaningful differences compared to reference products in pharmacokinetics (PK), pharmacodynamics (PD), safety or efficacy. Data from a Phase I showed Jubereq had a comparable PK profile to Xgeva in healthy adult males. The Phase III trial demonstrated that Osvyrti closely matched its reference product, Prolia, in postmenopausal women with osteoporosis, demonstrating no clinically meaningful differences across PK, PD, safety or efficacy measures.
Osvyrti includes a boxed warning for severe hypocalcemia in patients with advanced kidney disease and, similar to Prolia, is subject to an approved REMS program.
Accord is planning a commercial launch for the two products in 2026.
According to Accord, in 2024, global Prolia sales increased 8% year over year to more than $4.374 billion. Xgeva revenues rose 5% to $2.225 billion, making “both products among Amgen’s top five highest-selling drugs.”
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A slew of denosumab biosimilars have been steadily entering the market this year.
In March, Fresenius Kabi received FDA approval for its Prolia and Xgeva biosimilars, Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht), respectively.
In August, Shanghai Henlius Biotech and Organon’s Bildyos and Bilprevda were approved as interchangeable biosimilars to Prolia and Xgeva.
A month later, in September, another pair of approvals followed with Hikma Pharmaceuticals USA receiving FDA approval for its biosimilars Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), along with Biocon Biologics’ Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), as biosimilars to Prolia and Xgeva, respectively. All are approved as interchangeable to their reference products.
In 2024, biosimilar giant Sandoz’s denosumab biosimilars Jubbonti (denosumab-bddz) and Wyost (denosumab-bddz) were approved as the first interchangeable biosimilars to Prolia and Xgeva, respectively. This means they can be substituted for the reference product at a pharmacy without the need for instruction from a prescriber.
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