Novartis' Sandoz gets EMA review for biosimilar to Amgen's Prolia, Xgeva
Michael Derrer Fuchs
The European Medicines Agency (EMA) accepted to review Sandoz's applications for a proposed biosimilar to denosumab.
The applications by Sandoz â Novartis' (NYSE:NVS) generic and biosimilars unit â include all indications covered by the reference drugs, which are Amgen's (NASDAQ:AMGN) Prolia (denosumab) and Xgeva (denosumab).
The medicines are for treating certain conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, for treatment-induced bone loss, for preventing skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone.
"Sandoz is one of the first to have its applications for a proposed biosimilar denosumab accepted by the EMA," said Florian Bieber, Development Platform head Biopharmaceuticals and chief medical officer, Sandoz.
Bieber added that the news follows a recent application acceptance by the U.S. Food and Drug Administration.
The EMA filings are backed by data from a phase I PK/PD similarity study in healthy people and an integrated phase 1/3 ROSALIA study.
Sandoz is making efforts to expand its biosimilars footprint. Earlier this month, the company signed an agreement with Evotec's Seattle-based subsidiary Just - Evotec Biologics for developing and manufacturing multiple biosimilars.
The Novartis unit is also heading for a spin-off and the Swiss pharma giant is on track to make it happen in H2 2023. A 10-member board for the generics unit was recently announced as well.
Last year in August, Novartis said it was going to spin off Sandoz into a separate publicly traded standalone company to focus on innovative medicines.