Giant Cell Tumors

Wyost® (denosumab-bddz) and Jubbonti® (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference medicines Xgeva ®* (denosumab) and Prolia®* (denosumab) FDA approval based on robust clinical studies and totality of evidence, which show no clinically meaningful differences from reference medicines March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most." Wyost® is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat 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 to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.1 Bone is the third most frequent site for metastatic tumors.2 Nearly all types of cancer can spread to the bone and cause pain and fractures, though cancers that often metastasize in bones include breast and prostate.3 Jubbonti® is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat 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.4 Osteoporosis is a bone disease that develops when bone mineral density and bone mass decrease or when bone strength and structure change. People living with osteoporosis typically do not have symptoms and might not know they have the disease until they experience a fracture. More than 10 million US adults aged 50 and over live with osteoporosis, a major cause of fractures in postmenopausal women and in older men.5,6 Half of all women over the age of 50 will experience an osteoporotic fracture during their lifetime.7 The FDA approval is based on robust clinical studies and accompanied by labeling with safety warnings. The Jubbonti® approval is also accompanied by approval of Sandoz’s Jubbonti® Risk Evaluation and Mitigation Strategy (REMS) program, which is designed to inform prescribers and patients about the risk of severe hypocalcemia associated with Jubbonti® in patients with advanced chronic kidney disease, including dialysis-dependent patients. Wyost® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines. Wyost® and Jubbonti® are approved as interchangeable with the reference medicines for all indications. Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time. Wyost® 120 mg/1.7 mL (70 mg/mL) injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).8,9 Wyost® is indicated in the US to prevent SREs in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat 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 to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.1 Jubbonti® 60 mg/1 mL injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).8,9 Jubbonti® is indicated in the US to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat 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.4 References 1. Wyost®. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf [Last accessed: March 2024] 2. Bone Metastasis. Apoorva Jayarangaiah; Alysia K. Kemp; Pramod Theetha Kariyann, Oct 25 2022. Available at https://www.ncbi.nlm.nih.gov/books/NBK507911/#:~:text=The%20skeleton%20is%20the%20third,metastasize%20to%20bone%20as%20well. [Last accessed: March 2024] 3. American Cancer Society. Bone Metastases. Available at: https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/bone-metastases.html [Last accessed: March 2024] 4. Jubbonti®. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf [Last accessed: March 2024] 5. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Osteoporosis. 2022. Available at: https://www.niams.nih.gov/health-topics/osteoporosis [Last accessed: March 2024] 6. National Center for Health Statistics. Osteoporosis or Low Bone Mass in Older Adults: United States, 2017–2018. 2021. Available at: https://www.cdc.gov/nchs/products/databriefs/db405.htm [Last accessed: March 2024] 7. Bone Health and Osteoporosis Foundation. Osteoporosis Fast Facts. Available at: https://www.bonehealthandosteoporosis.org/wp-content/uploads/Osteoporosis-Fast-Facts-2.pdf [Last accessed: March 2024] 8. Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf [Last accessed: March 2024] 9. Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf [Last accessed: March 2024] Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion. 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The FDA approval positions Wyost as a treatment to prevent skeletal-related events. Credit: BigPixel Photo / Shutterstock.com. The US Food and Drug Administration (FDA) has approved Sandoz ’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), marking the introduction of the first FDA-approved denosumab biosimilars. These biosimilars are authorised to treat all indications of their reference medicines. With a concentration of 120mg/1.7mL (70mg/mL), Wyost is indicated as interchangeable with its reference medicine, a human monoclonal antibody that acts on the RANKL protein, which is essential for the activation of osteoclasts. This approval positions Wyost as a treatment to prevent skeletal-related events in patients with multiple myeloma and for those with bone metastases caused by solid tumours. Wyost is also sanctioned for use in adults and skeletally mature adolescents with giant cell tumours in bone that are either unresectable or where surgical resection could cause significant morbidity. See Also: A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer FDA doubles down on patient engagement to support rare disease research It is also approved for treating hypercalcaemia of malignancy resistant to bisphosphonate treatment. Jubbonti is indicated to address several conditions related to bone health. It is approved for treating high fracture risk in postmenopausal women with osteoporosis, for improving bone mass in men with osteoporosis at similar risk, and for managing glucocorticoid-induced osteoporosis in anyone with this risk. Jubbonti is also approved to augment bone mass in men at high fracture risk due to undergoing androgen deprivation treatment for non-metastatic prostate cancer, and women receiving adjuvant aromatase inhibitor therapy for breast cancer. Extensive clinical studies support the latest regulatory approval in the US for these biosimilars and include safety warnings within the labelling. The approval of Jubbonti is paired with the sanctioning of Sandoz’s Jubbonti Risk Evaluation and Mitigation Strategy (REMS) programme. The programme is tailored to educate prescribers and patients about potential severe hypocalcaemia risk, particularly in those with advanced chronic kidney disease, including those dependent on dialysis. Sandoz North America president Keren Haruvi stated: “Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events […] disease states that can profoundly reduce the quality of life for patients.” The latest development comes after Sandoz acquired US biosimilar CIMERLI from Coherus BioSciences .

Pictured: FDA's signage at its headquarters/iStock, JHVEPhoto The FDA on Tuesday approved two of Sandoz’s biosimilars for Amgen’s blockbuster bone-preserving therapy denosumab, though the Novartis spin-off is keeping mum on its target launch date, pricing and other launch details. Sandoz’s Jubbonti will challenge Amgen’s Prolia for the treatment of osteoporotic men and postmenopausal women who are at high risk of fracture. Like its branded reference product, the biosimilar is also indicated for glucocorticoid-induced osteoporosis. Jubbonti can also be used to boost bone mass in men undergoing androgen deprivation therapy for nonmetastatic cancer, as well as women at high risk of fractures and who are being treated with adjuvant aromatase inhibitors for breast cancer. Amgen’s Xgeva will face off against Sandoz’s Wyost, which can now be used to prevent skeletal-related events in patients with multiple myeloma and solid tumors with bone metastases. The biosimilar is also approved to treat unresectable giant cell tumor of the bone and hypercalcemia of malignancy refractory to bisphosphonate therapy. Jubbonti and Wyost have the same dosage form, route of administration, dosing regimen and presentation as their respective reference products. The two biosimilars have also won the FDA’s interchangeability designation, allowing them to be substituted for Prolia and Xgeva without needing to change the patient’s prescription. Sandoz North America President Keren Haruvi in a statement said that Jubbonti and Wyost represent “the first FDA approval for biosimilars to denosumab” which can help improve access to life-changing treatment for patients suffering from osteoporosis and cancer-related bone events. However, due to “ongoing patent litigation” surrounding the biosimilars, Sandoz has not disclosed its expected launch timelines for Jubbonti and Wyost including other details such as pricing. Denosumab is a fully human monoclonal antibody that targets and binds the RANKL cytokine, which is a central player in bone turnover. By blocking the RANKL signaling cascade, denosumab can inhibit bone the resorption process and increase bone strength and mass. Denosumab was first approved in June 2010 as Prolia for use in postmenopausal women with osteoporosis. The antibody won its second approval as Xgeva a few months later in November 2010 to prevent skeletal events in solid tumor patients with bone metastases. Both therapies have since become strong commercial assets for Amgen. In 2023, Prolia brought in over $4 billion in revenue, representing a 12% increase from its 2022 sales of nearly $3.63 billion. Xgeva also demonstrated strong 5% year-over-year sales growth, reaching $2.1 billion in 2023 from a little more than $2 billion in 2022. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.