PROLIA® (denosumab)
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 U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo)
 The Manila Times· 2025-10-30 15:53
 The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 29, 2025The interchangeability (IC) designations of STOBOCLO and OSENVELT were granted based not only on the comparative clinical data - including pharmacokinetics, efficacy, safety and an immunogenicity study in postmenopausal women with osteoporosis[1] - but also on ana ...