Core Viewpoint - Celltrion, Inc. has received FDA designation for its biosimilars STOBOCLO® and OSENVELT® as interchangeable with the reference products PROLIA® and XGEVA®, respectively, for all approved indications, enhancing patient access and treatment options in the U.S. market [1][5]. Group 1: Product Information - STOBOCLO® (denosumab-bmwo) is indicated for treating postmenopausal women with osteoporosis at high risk for fracture, increasing bone mass in men with osteoporosis, and treating glucocorticoid-induced osteoporosis [4][6]. - OSENVELT® (denosumab-bmwo) is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases, treating unresectable giant cell tumor of bone, and managing hypercalcemia of malignancy [17][21]. Group 2: Regulatory Designation - The FDA's interchangeability designation allows STOBOCLO and OSENVELT to be substituted for their reference products at pharmacies without consulting the prescriber, subject to state laws [3][5]. - The designations were based on comprehensive clinical data, including Phase III trial results demonstrating efficacy, safety, and pharmacokinetics in postmenopausal women with osteoporosis [3][5]. Group 3: Market Impact - The interchangeability designations are expected to reinforce confidence among healthcare providers, facilitating a smoother transition to these biosimilars and potentially leading to cost savings for patients and the U.S. healthcare system [3][5]. - STOBOCLO and OSENVELT were introduced to the U.S. market in July 2025, with STOBOCLO available in a 60 mg/mL injection and OSENVELT in a 120 mg/1.7 mL (70 mg/mL) injection [3][4].

Core Viewpoint - Sandoz has launched WYOST® and Jubbonti®, the first and only interchangeable FDA-approved denosumab biosimilars in the US, aimed at improving access to treatment for osteoporosis and cancer-related skeletal events [2][7]. Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a growth strategy focused on pioneering access for patients. The company recorded net sales of USD 10.4 billion in 2024 and has a portfolio of approximately 1,300 products [21]. Product Launch Details - WYOST® and Jubbonti® are approved for all indications of the reference medicines XGEVA® and Prolia®, respectively, and are integral to Sandoz's growth strategy in the biosimilar market [2][3]. - The products are designed to provide high-quality, cost-effective treatment options, enhancing patient access and affordability in the US [3][5]. Patient Impact - The introduction of these biosimilars is expected to significantly improve treatment access for over 10 million US adults aged 50 and older living with osteoporosis, as well as for approximately 330,000 individuals with bone metastases [5][6]. - Sandoz is providing comprehensive support resources for patients prescribed these medications, including reimbursement and financial assistance [4]. Regulatory Approval - Both WYOST® and Jubbonti® have been approved as interchangeable with their reference medicines, ensuring they have the same dosage form, route of administration, and dosing regimen [3][6].