{"id":118254,"date":"2025-11-06T08:23:19","date_gmt":"2025-11-06T08:23:19","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/118254\/"},"modified":"2025-11-06T08:23:19","modified_gmt":"2025-11-06T08:23:19","slug":"denosumab-biosimilars-stoboclo-osenvelt-get-interchangeability-designation","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/118254\/","title":{"rendered":"Denosumab Biosimilars Stoboclo, Osenvelt Get Interchangeability Designation"},"content":{"rendered":"<p>The Food and Drug Administration (FDA) has designated Stoboclo\u00ae (denosumab-bmwo) and Osenvelt\u00ae (denosumab-bmwo) as interchangeable biosimilars to the reference products <a href=\"https:\/\/www.empr.com\/drug\/prolia\/\" rel=\"nofollow noopener\" target=\"_blank\">Prolia\u00ae<\/a> (denosumab) and <a href=\"https:\/\/www.empr.com\/drug\/xgeva\/\" rel=\"nofollow noopener\" target=\"_blank\">Xgeva\u00ae<\/a> (denosumab), respectively.<\/p>\n<p><a href=\"https:\/\/www.empr.com\/drug\/stoboclo\/\" rel=\"nofollow noopener\" target=\"_blank\">Stoboclo<\/a> is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.<\/p>\n<p><a href=\"https:\/\/www.empr.com\/drug\/osenvelt\/\" rel=\"nofollow noopener\" target=\"_blank\">Osenvelt<\/a> is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to biphosphonate therapy.<\/p>\n<p>The FDA <a href=\"https:\/\/www.empr.com\/news\/denosumab-biosimilars-stoboclo-osenvelt-approved\/\" rel=\"nofollow noopener\" target=\"_blank\">approved<\/a> Stoboclo and Osenvelt as biosimilars in March 2025. The interchangeability designation was based on the same clinical data package used for approval, which included a phase 3 trial (ClinicalTrials.gov Identifier: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04757376\" rel=\"nofollow noopener\" target=\"_blank\">NCT04757376<\/a>) that compared denosumab-bmwo to the reference product (Prolia) in postmenopausal women with <a href=\"https:\/\/www.rheumatologyadvisor.com\/news\/bone-related-biomarkers-unrelated-to-incident-hip-fractures\/\" rel=\"nofollow noopener\" target=\"_blank\">osteoporosis<\/a>.\u00a0<\/p>\n<p>Findings showed no clinically meaningful differences in efficacy, safety, pharmacokinetic, and immunogenicity data between denosumab-bmwo and Prolia at week 52. Comparable efficacy results were also observed at week 78 after switching to the biosimilar from the reference product.<\/p>\n<p>The interchangeability designation allows Stoboclo and Osenvelt to be substituted at the pharmacy for the reference product without a prescriber\u2019s consultation, subject to state pharmacy laws.<\/p>\n<p>\u201cToday\u2019s [interchangeability] designations reinforce confidence in Stoboclo and Osenvelt among physicians and pharmacists, facilitating a more seamless switch from the reference products to our <a href=\"https:\/\/www.rheumatologyadvisor.com\/news\/fda-approves-denosumab-biosimilars-enoby-and-xtrenbo\/\" rel=\"nofollow noopener\" target=\"_blank\">denosumab<\/a> biosimilars,\u201d said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA.<\/p>\n<p>Stoboclo is supplied as a 60mg\/mL solution in a single-dose prefilled syringe. Osenvelt is supplied as a 120mg\/1.7mL solution in a single-dose vial.\u00a0<\/p>\n<p>This article originally appeared on <a href=\"https:\/\/www.empr.com\/news\/denosumab-biosimilars-stoboclo-osenvelt-get-interchangeability-designation\/\" target=\"_blank\" rel=\"nofollow noopener\">MPR<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The Food and Drug Administration (FDA) has designated Stoboclo\u00ae (denosumab-bmwo) and Osenvelt\u00ae (denosumab-bmwo) as interchangeable biosimilars to the&hellip;\n","protected":false},"author":2,"featured_media":118255,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":{"0":"post-118254","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-il","10":"tag-israel","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/118254","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=118254"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/118254\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/118255"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=118254"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=118254"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=118254"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}