Sandoz Rolls Out Interchangeable Denosumab Biosimilars, Expanding Access For Millions In The U.S.

Sandoz, a global leader in generic and biosimilar medicines, has announced the availability of WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) to patients in the United States starting today. These two biosimilars are the first and only FDA-approved interchangeable versions of denosumab and are approved for all the same indications as their respective reference biologics, XGEVA® (denosumab) and Prolia® (denosumab). This milestone represents a significant advancement in improving access to critical treatments for patients with cancer-related bone conditions and osteoporosis.

The launch of WYOST® and Jubbonti® reinforces Sandoz’s leadership in the biosimilars space, particularly in oncology and bone health. Since introducing the first biosimilar in the US in 2015, Sandoz has remained committed to increasing access to high-quality, affordable biologic medicines. These two new biosimilars play a key role in the company’s US growth strategy, aiming to strengthen its position as a leading provider of biosimilars in the American market.

WYOST® and Jubbonti® offer the same dosage form, route of administration, dosing schedule, and presentation as the original reference medicines. Their interchangeable status means that pharmacists can substitute them for the branded versions without requiring a new prescription, where state laws allow. Both products will launch with an established Q code and will be supported by Sandoz through a comprehensive range of patient resources, including reimbursement assistance and financial support programs.

Keren Haruvi, President Sandoz North America, said in a statement, “Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients.”

Claire Gill, Chief Executive Officer, Bone Health and Osteoporosis Foundation, mentioned, “Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve.”

These biosimilars are intended to address serious medical conditions. Bone metastases, a common complication in patients with cancers such as breast, prostate, lung, kidney, and thyroid, can lead to painful and debilitating skeletal-related events (SREs). An estimated 330,000 people in the US are living with bone metastases. In addition, osteoporosis affects over 10 million adults aged 50 and older in the US, with another 43 million at risk due to low bone mass. The condition significantly increases the likelihood of fractures, especially in women and older adults. With the launch of WYOST® and Jubbonti®, Sandoz is offering patients more treatment options while also supporting the broader goals of healthcare sustainability and affordability through biosimilar innovation.