Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable biosimilars to the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications. The interchangeability (IC) designation is a regulatory designation granted by the FDA, which means STOBOCLO and OSENVELT may now be substituted at the pharmacy for the reference products without consulting the prescriber, subject to state laws. The interchangeability designations of STOBOCLO and OSENVELT were based on the comprehensive evidence including the clinical results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of denosumab biosimilar to its reference product.
STOBOCLO and OSENVELT were introduced in the U.S. market in July 2025. STOBOCLO is currently available in 60 mg/mL injection and OSENVELT is offered in 120 mg/1.7 mL (70 mg/mL) injection. According to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA).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.
