EMA Accepts MAAs from Sandoz for Proposed Denosumab Biosimilar

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Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

Sandoz, a Novartis division specializing in off-patent (generic and biosimilar) therapeutics, announced on May 25, 2023 that the European Medicines Agency (EMA) has accepted its two marketing authorization applications (MAAs) for a proposed biosimilar to denosumab. Denosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of the bone, according to a company press release.

Sandoz’s two MAAs include all indications covered by the reference biologics, Amgen’s Prolia (denosumab) and Xgeva (denosumab), respectively. The indications include treating osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal- related complications in cancer that have spread to the bone, and giant cell tumor of the bone.

The applications include a comprehensive analytical and clinical data package, which comprises data from a Phase I pharmacokinetic/pharmacodynamic (PK/PD) similarity study in healthy volunteers and an integrated Phase I/III study (ROSALIA). According to the data package, Sandoz’s denosumab biosimilar matches the reference biologic in relation to PK, PD, efficacy, safety, and immunogenicity in the respective populations used in the studies. The data also contribute to the demonstration of similarity, which forms the basis for the biosimilar’s use in all indications for which Xgeva and Prolia are approved, according to the press release.


“Sandoz is one of the first to have its applications for a proposed biosimilar denosumab accepted by the EMA. If approved, this has the potential to provide people living with osteoporosis and cancer of the bone or bone metastasis access to a cost-effective and high-quality treatment option,” said Florian Bieber, development platform head Biopharmaceuticals and chief medical officer, Sandoz, in the press release. “This news follows the recent application acceptance by [FDA] and supports our continued commitment to providing expanded access to life-changing treatments, while also helping over-burdened healthcare systems generate savings.”

Source: Novartis