Sandoz has received news that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for their proposed biosimilar denosumab. These applications cover all indications of the reference medicines Prolia® and Xgeva® for various conditions, including osteoporosis, treatment-induced bone loss, and bone complications in cancer.
If approved, Sandoz's biosimilar denosumab could offer a cost-effective and high-quality treatment option for individuals with osteoporosis and bone-related cancers. This development aligns with Sandoz's commitment to expanding access to life-changing treatments and supporting healthcare systems with savings.
Osteoporosis affects millions worldwide, causing millions of fractures annually. The prevalence of skeletal complications in cancer is also significant. By providing a biosimilar option, Sandoz aims to address these pressing healthcare challenges.
The MAA submissions to the EMA are backed by extensive analytical and clinical data, including Phase I studies in healthy volunteers and the integrated Phase I/III ROSALIA study. The data package confirms the similarity of the biosimilar denosumab to the reference medicine in terms of efficacy, safety, and other critical parameters.
This progress marks an important step forward in Sandoz's pursuit of bringing their biosimilar denosumab to market and providing accessible treatment options to those in need.
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