The European Medicines Agency (EMA) has accepted two marketing authorization (MA) applications from Sandoz for the proposed biosimilar denosumab.
The marketing authorizations include all the indications covered by the reference medicines Xgeva (denosumab) and Prolia (denosumab) to treat conditions such as osteoporosis in postmenopausal women.
Other conditions include the prevention of skeletal-related complications in cancer that has spread to the bones, as well as treatment-induced bone loss.
Florian Bieber, Sandoz Medical Director and Head of Biopharmaceuticals Development Platform, said, “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 with osteoporosis and bone cancer or bone metastases access to a cost-effective, high-quality treatment option.
“This news follows the recent acceptance of the application by the U.S. Food and Drug Administration and supports our continued commitment to providing expanded access to life-changing treatments while helping overstretched healthcare systems generate savings.”
The submission was supported by a comprehensive set of analytical and clinical data, including data from a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trial.
The results showed that denosumab matched the reference drug in terms of safety, pharmacodynamics, efficacy, pharmacokinetics and immunogenicity in study participants.