Celltrion announced that the FDA has granted interchangeability designation to its denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), for all approved indications. The designation allows these biosimilars to be substituted at the pharmacy for the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, without the need for prescriber intervention, subject to state laws.
The interchangeability status was awarded based on comprehensive clinical data, including pharmacokinetics, efficacy, safety, and immunogenicity studies in postmenopausal women with osteoporosis, as well as analytical data demonstrating similarity to the reference products. STOBOCLO is indicated for the treatment of osteoporosis-related fractures, while OSENVELT is used for cancer-related bone loss and other skeletal events.
This regulatory milestone is expected to enhance patient access and provider choice in the management of osteoporosis and cancer-related bone complications. STOBOCLO and OSENVELT were first introduced in the U.S. market in July 2025 and are available in 60 mg/mL and 120 mg/1.7 mL (70 mg/mL) injection strengths, respectively.
The FDA's interchangeability designation is a significant step for biosimilar adoption, as it streamlines substitution and may help reduce treatment costs for patients and healthcare systems.
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