EMA accepts STADA’s filing for AVT03, a proposed denosumab biosimilar

The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel (SAZ: Xetra).

Marketed by US biotech major Amgen (Nasdaq: AMGN), the denosumab brands are used, respectively, to treat osteoporosis and for preventing bone complications associated with advanced cancer. STADA is seeking approval for the same indications, dosage form, route of administration and dosing regimen as the respective reference medicines.

In May this year, Swiss generic and biosimilar medicines company Sandoz (SWX: SDZ) was granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe.