Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology and central nervous system (CNS) therapies, today announced the launch of two denosumab biosimilars—OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)—expanding access to more affordable therapies for patients. OSVYRTI and JUBEREQ are FDA-approved as interchangeable biosimilars to Prolia® and XGEVA®, respectively, and represent Accord BioPharma's first products developed and manufactured end to end, by its parent entity.

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. As an interchangeable biosimilar to Prolia, OSVYRTI carries a Boxed Warning for severe hypocalcemia in patients with advanced kidney disease and was approved with a Risk Evaluation and Mitigation Strategy (REMS) program through which Accord will fulfill obligations related to such warning.

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 Please see below for Important Safety Information for OSVYRTI and JUBEREQ.

Strengthening Access to Treatment for Certain Bone Health Conditions

"For patients living with osteoporosis or cancer-related bone loss, the ability to access proven therapy is vital," said Chrys Kokino, President, Accord North America. "With the simultaneous launch of OSVYRTI and JUBEREQ, we are proud to provide access to additional options for these critical conditions and to back that commitment with real support for patients through AccordCares, our patient support program."

Bone health conditions, including those for which OSVYRTI and JUBEREQ are approved, represent a significant and growing burden on patients and the U.S. healthcare system. Fragility fractures affect approximately 1.9 million Americans annually and are responsible for approximately 500,000 hospital admissions and 180,000 nursing home admissions. The annual number of fractures is projected to increase to 3.2 million by 2040.⁵ An estimated 300,000 to 600,000 Americans are living with cancer-related bone metastases from solid tumors at any given time, and more than 35,000 Americans are diagnosed with multiple myeloma each year — a disease commonly associated with bone complications.^6-7 In 2024, Medicare Part B spending on denosumab products exceeded $2 billion, underscoring the need for more affordable alternatives.

OSVYRTI is available at a wholesaler acquisition cost (WAC) of $1,800.41 per 60 mg/mL single-dose pre-filled syringe, and JUBEREQ at a WAC price of $3,311.75 per 120 mg/1.7 mL (70 mg/mL) single-dose vial, supplying providers with more cost-efficient acquisition options for denosumab therapy.

Beyond pricing, Accord BioPharma has worked to ensure broad coverage of these products at launch. As of July 1^st, both brands are Preferred on Cigna Advantage, Performance, and Legacy Performance commercial pharmacy benefit drug lists. Additionally, on September 1^st, both brands will be Preferred on the Cigna commercial medical benefit. Through AccordCares, eligible commercially insured patients may be able to access both OSVYRTI and JUBEREQ for as little as $0.

A Milestone in Accord BioPharma's Growth

Launching OSVYRTI and JUBEREQ marks another step in Accord BioPharma's evolution as a fully integrated biosimilar company: one that drives the science, the process, and the outcome. The company's goal of bringing 20 biosimilars to the U.S. market by 2030 reflects not just its ambition but also its infrastructure to deliver on it.

"OSVYRTI and JUBEREQ represent a proud milestone in our work with Accord BioPharma to independently manufacture and bring these biosimilars to the U.S. market," said Binish Chudgar, Chairman and Managing Director of Intas. "Biosimilars have a critical and lasting role to play in the U.S. healthcare system, and we remain committed to helping more patients access the proven therapies they need, while delivering meaningful cost savings."