Clin Osteol 2025; 30(2): 96-99
Biosimilární denosumab CT-P41 v terapii osteoporózyPůvodní práce
- Ústav farmakologie LF UP a FN Olomouc
Denosumab je monoklonální protilátka IgG2 cílená proti ligandu receptorového aktivátoru nukleárního faktoru kappa-B (RANKL), který je klíčovým regulátorem kostní resorpce osteocyty. Terapie tímto biologickým léčivem je účinnou a bezpečnou možností léčby osteoporózy různé etiologie. Denosumab CT-P41 je biosimilárním přípravkem, který byl v březnu 2025 registrován Evropskou lékovou agenturou pod názvem Stoboclo pro použití v osteologii. V preklinickém i klinickém hodnocení prokázal kvalitu, bezpečnost a účinnost v terapii ztrát kostní hmoty srovnatelnou s originálním přípravkem. Jeho zavedení do klinické praxe zlepší dostupnost nákladné biologické léčby osteoporózy.
Klíčová slova: biosimilar, denosumab, osteoporóza.
Biosimilar denosumab CT-P41 in the treatment of osteoporosis
Denosumab is an IgG2 monoclonal antibody targeted against receptor activator of nuclear factor kappa-B (RANKL) ligand, a key regulator of bone resorption by osteocytes. Therapy with this biologic is an effective and safe treatment option for osteoporosis of various aetiologies. Denosumab CT-P41 is a biosimilar that was registered by the European Medicines Agency in March 2025 under the name Stoboclo for use in osteology. In preclinical and clinical trials, it has demonstrated quality, safety and efficacy in the treatment of bone loss comparable to the brand-name. Its introduction into clinical practice will improve the availability of expensive biological treatment for osteoporosis.
Keywords: biosimilar, denosumab, osteoporosis.
Zveřejněno: 1. červen 2025 Zobrazit citaci
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