Sandoz files Amgen biosimilar drug for osteoporosis

pharmafile | February 8, 2023 | News story | Research and Development  

Switzerland-based Sandoz has filed a proposed biosimilar of Amgen’s osteoporosis drug Prolia/Xgeva with the FDA. According to Sandoz, over 10 million US adults over the age of 50 have osteoporosis, with 80% of them being women.


Prolia/Xgeva’s active ingredient ‒ RANKL inhibitor denosumab ‒ was approved in 2010 and currently has patent protection in the US until 2025. Prolia earned Amgen $3.6bn in 2022, with nearly $2.5bn coming from the US market. Xgeva, a higher-dose denosumab-based product which is used to treat tumours that have spread to the bone, as well as hypercalcaemia, brought in $2bn, with $1.5bn coming from the US.


Sandoz’s biosimilar application covers all the same indications that Prolia and Xgeva do, including osteoporosis in premenopausal women and in men with increased risk of fractures, treatment-induced bone loss, prevention of skeletal complications in cancer which has spread to the bone, giant cell tumours of the bone and treatment of hypercalcaemia caused by cancer which doesn’t respond to bisphosphonate therapy.


The FDA’s review of Sandoz’s application will include a thorough look at data from the phase 1/3 ROSALIA study, which showed that the biosimilar matched Amgen’s denosumab on multiple pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity measures in postmenopausal women with osteoporosis.


“We are proud to be among the first to submit a biologics license application for a denosumab biosimilar as, if approved, it could increase patient access to an affordable, high-quality, potentially disease-modifying treatment across the US, while also delivering savings for healthcare systems,” stated Keren Haruvi, head of Sandoz’ North America operations.


James Spargo

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