FDA nod for two Celltrion denosumab biosimilars

South Korea-based Celltrion (Kosdaq: 068270) today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Amgen’s (Nasdaq: AMGN) Prolia and Xgeva brands respectively for all indications of the reference products.

"The approval of Stoboclo and Osenvelt is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporos1is-related fracture as well as cancer-related skeletal events," said Thomas Nusbickel, chief commercial officer at Celltrion USA. "Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives. We are committed to continuous innovation to meet these goals leveraging our experience and successful track record with biosimilar and novel biologics," he noted.

In accordance with a settlement agreement with Amgen, Stoboclo and Osenvelt are expected to be available in the USA in June 2025.