Teva Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) has approved denosumab-adet, a biosimilar to denosumab, across all indications of the reference product.
The approval expands Teva’s biosimilar portfolio in oncology and bone health, providing a new treatment option for patients requiring denosumab-based therapy.
Denosumab-adet is approved for the prevention of skeletal-related events in adults with advanced cancer that has spread to bone, the treatment of adults and skeletally mature adolescents with giant cell tumor of bone, and the treatment of hypercalcemia of malignancy.
Denosumab Biosimilar in Oncology Care
Denosumab is a human monoclonal antibody targeting receptor activator of nuclear factor kappa-B ligand (RANKL), a key regulator of osteoclast formation, function, and survival.
By inhibiting RANKL activity, denosumab reduces bone resorption and helps prevent complications associated with cancer involving the bone, including fractures and other skeletal-related events.
The FDA approval of denosumab-adet was supported by a totality of evidence, including analytical and clinical data demonstrating similarity to the reference product, with comparable efficacy, safety, and immunogenicity profiles.
Teva Expands Biosimilar Portfolio
The approval represents another step in Teva’s biosimilar strategy, with the company continuing to expand access to biologic medicines across therapeutic areas.
Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, said:
“The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine. The approval of DEGEVMA is a powerful example of Teva’s Pivot to Growth strategy in action because it represents an important step in expanding treatment options for patients and supporting healthcare systems with a high-quality biosimilar.”
Teva stated that the approval strengthens its position in the U.S. biosimilars market and supports its efforts to provide additional options for patients and healthcare systems.
Growing Role of Biosimilars in Cancer Care
Biosimilars are biologic medicines that are highly similar to an already approved reference product, with no clinically meaningful differences expected in terms of safety, purity, and effectiveness.
As biosimilars continue to enter oncology practice, they are becoming an increasingly important component of strategies aimed at supporting access to complex biologic therapies.
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