This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without intervention of the prescribing healthcare provider.
On October 29, Fresenius Kabi announced that the FDA granted an interchangeability designation for CONEXXENCE® and BOMYNTRA® (denosumab-bnht), Fresenius Kabi’s biosimilars to Amgen’s PROLIA® (denosumab) and XGEVA® (denosumab), respectively. The two products were originally approved by the FDA on March 25, 2025.
On October 30, Celltrion similarly announced that the FDA granted an interchangeability designation for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), Celltrion’s biosimilars to Amgen’s PROLIA® and XGEVA®. According to Celltrion, these interchangeability designations “were granted based not only on the comparative clinical data … but also on analytical data demonstrating similarity of STOBOCLO and OSENVELT versus the reference product.” Celltrion also noted that, “[a]ccording to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA). Previously, the FDA granted this status only to biosimilars that submitted multiple switch studies meeting additional data criteria.” Celltrion’s denosumab biosimilars were originally approved by the FDA on February 28, 2025.