RALEIGH, N.C., July 23, 2026
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, has announced the commercial availability of OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), two FDA-approved interchangeable denosumab biosimilars developed to expand patient access to affordable therapies for osteoporosis, cancer-related bone disease, and other serious skeletal conditions. The dual launch marks a major milestone for the company, representing the first products developed and manufactured entirely by its parent organization while reinforcing Accord BioPharma’s long-term strategy to become a leading biosimilar provider in the United States. The new therapies are interchangeable biosimilars to Prolia® and XGEVA®, respectively, providing healthcare providers and patients with additional treatment options while helping reduce healthcare costs associated with biologic therapies. The launch also supports the growing adoption of biosimilars across oncology and bone health treatment, where increasing patient demand continues to drive the need for cost-effective biologic alternatives.
Dual Biosimilar Launch Expands Treatment Options for Bone Health
The introduction of OSVYRTI® and JUBEREQ® significantly strengthens the availability of biosimilar therapies for patients with osteoporosis and cancer-related bone complications. OSVYRTI is approved for treating postmenopausal osteoporosis, increasing bone mass in men with osteoporosis, managing glucocorticoid-induced osteoporosis, and preventing bone loss associated with hormone therapies used in prostate and breast cancer. The product is also an interchangeable biosimilar to Prolia® and includes a Risk Evaluation and Mitigation Strategy (REMS) due to its boxed warning regarding severe hypocalcemia in patients with advanced kidney disease. JUBEREQ, an interchangeable biosimilar to XGEVA®, is indicated for the prevention of skeletal-related events in patients with multiple myeloma, bone metastases from solid tumors, treatment of giant cell tumor of bone, and management of hypercalcemia of malignancy that is resistant to bisphosphonate therapy. Together, these approvals provide clinicians with additional evidence-based biologic treatment options while supporting broader adoption of biosimilars across oncology and bone disease management.
Improving Access Through Affordable Biosimilar Medicines
Accord BioPharma emphasized that increasing patient access remains a central objective of the simultaneous launch. According to the company, bone health disorders continue to place a substantial burden on healthcare systems, with approximately 1.9 million fragility fractures occurring annually in the United States and fracture rates expected to rise significantly over the coming decades. In oncology, hundreds of thousands of patients live with bone metastases, while multiple myeloma frequently results in severe skeletal complications requiring long-term treatment. To address affordability, Accord BioPharma introduced competitive wholesale acquisition pricing while securing preferred formulary positions with major commercial health plans. Through the company’s AccordCares patient support program, eligible commercially insured patients may obtain both biosimilars with minimal out-of-pocket costs, further improving treatment accessibility and helping healthcare providers deliver cost-effective biologic therapies without compromising clinical quality.
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Strategic Milestone Strengthens Accord BioPharma’s Biosimilar Pipeline
The commercial introduction of OSVYRTI® and JUBEREQ® represents an important strategic milestone in Accord BioPharma’s transformation into a fully integrated biosimilar developer and manufacturer. The company stated that these launches demonstrate its capability to independently manage the complete development, manufacturing, regulatory, and commercialization process for complex biologic medicines. Looking ahead, Accord BioPharma plans to introduce 20 biosimilar products in the U.S. by 2030, further expanding competition within the biologics market and supporting broader patient access to advanced therapies. As healthcare systems continue to prioritize affordability while maintaining high clinical standards, biosimilars are expected to play an increasingly important role in oncology, immunology, and chronic disease management. The successful launch of these two denosumab biosimilars reinforces Accord BioPharma’s growing position in the U.S. biosimilars market while contributing to the long-term sustainability of biologic healthcare delivery.
Source: Accord BioPharma press release
