The US Food and Drug Administration announced that Sandoz has won the race to bring a denosumab biosimilar to the finish line. The reference product by Amgen (sold under the Prolia® and Xgeva® brands) will face competition from Jubbonti®, and Wyost®, respectively. Furthermore, the FDA has designated the biosimilar as interchangeable. The assigned nonproprietary name is denosumab-bbdz.
Jubbonti is approved for the following indications:
- The treatment of men and postmenopausal women with osteoporosis at high risk for fracture
- The treatment of 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
- To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Wyost is indicated for:
- The prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
- The treatment of 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
- The treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy
Denosumab is a RANK ligand inhibitor that is administered by subcutaneous injection, generally administered by a healthcare professional, and thus covered under the medical benefit. Since the agent will not be subject to automatic substitution at the pharmacy, it is unclear how the interchangeability designation will be relevant. (This is the second time the FDA has awarded the designation to a drug covered under Part B or the medical benefit.)
In a press release announcing the denosumab biosimilar approval, 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.” Ms. Haruvi continued, “I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most.”
In its press release, Sandoz stated, “Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time.”
This will be a highly contested disease category; as many as 12 companies have products in the pipeline. The main patent expiration is in February 2025, and several launches are expected next year. Amgen’s combined US revenues for Prolia and Xgeva in 2023 were about $4 billion.
In other Sandoz news, the company announced it had completed the acquisition of Cimerli®, the ranibizumab biosimilar purchased from Coherus Biosciences.
