Thursday, June 12, 2025

Sandoz Rolls Out Exclusive Interchangeable Denosumab Biosimilars in US

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Sandoz has officially made available WYOST® and Jubbonti®, the United States’ first FDA-approved interchangeable biosimilars of denosumab, offering affordable treatment alternatives to over 10 million Americans battling osteoporosis and cancer-related bone complications.

Expanding Access to Essential Treatments

The introduction of WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) marks a significant advancement in the treatment landscape for conditions such as osteoporosis and cancer-induced skeletal events. These biosimilars are engineered to match the dosage form, administration route, and regimen of their reference counterparts, XGEVA® and Prolia®, ensuring seamless integration into existing treatment protocols.

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Strengthening Sandoz’s Biosimilar Portfolio

Building upon Sandoz’s established expertise in oncology and immunology biosimilars since 2015, WYOST® and Jubbonti® enhance the company’s portfolio and support its growth strategy. By offering interchangeable options, Sandoz reinforces its commitment to delivering high-quality, cost-effective medicines that improve patient access and healthcare outcomes.

Keren Haruvi, President of Sandoz North America, emphasized the importance of these biosimilars in providing necessary treatment options. “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,” she stated.

Both WYOST® and Jubbonti® come with comprehensive support, including reimbursement and financial assistance programs, to ensure patients receive the necessary treatments without financial barriers. The interchangeable approval by the FDA allows for automatic substitution at the pharmacy level, facilitating easier access for patients.

Claire Gill, CEO of the Bone Health and Osteoporosis Foundation, highlighted the impact of these biosimilars. “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,” she affirmed.

Osteoporosis affects over 10 million adults in the US, with millions more at risk of fractures due to low bone mass. Similarly, bone metastases from various cancers pose significant health challenges, underscoring the need for accessible and affordable treatment solutions like WYOST® and Jubbonti®.

The launch includes robust safety information and guidelines to ensure the safe use of these biosimilars. Sandoz continues to prioritize patient safety by providing detailed prescribing information and monitoring protocols to healthcare providers.

**Key Inferences:**
– *Enhanced affordability* through interchangeable biosimilars can significantly reduce treatment costs for patients.
– *Increased access* to denosumab products may result in better management of osteoporosis and reduced skeletal events in cancer patients.
– *Strengthened market position* for Sandoz as a leader in biosimilars, particularly in oncology and immunology.

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The availability of WYOST® and Jubbonti® not only broadens the treatment options for patients but also promotes competitive pricing in the biosimilar market. Healthcare providers can anticipate improved patient adherence to treatment plans due to the reduced financial burden, leading to better overall health outcomes. Furthermore, the seamless substitution capability streamlines the prescribing process, making it easier for patients to receive timely and appropriate care. As Sandoz continues to innovate in the biosimilar arena, patients can expect ongoing advancements that enhance both access and quality of care across various therapeutic areas.

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