On March 3, Celltrion announced that the FDA has approved the company’s denosumab biosimilars Stoboclo (reference product, Prolia) and Osenvelt (reference product Xgeva). The nonproprietary designation for both molecules is denosumab-bmwo.
The approval covers all indications of the reference products, including osteoporosis with high risk of fracture in men and postmenopausal women, glucocorticoid-induced osteoporosis, increasing bone mass in men receiving androgen-deprivation therapy for prostate cancer and in women receiving adjuvant aromatase inhibitor therapy for breast cancer, and for oncology-related indications affecting the skeletal system.
Celltrion had conducted a phase 3 clinical trial in postmenopausal women with osteoporosis proving equivalent efficacy and safety to Prolia. However, the FDA approval was based on the totality of structural characterization, pharmacokinetic, pharmacodynamic, and clinical evidence.
“The approval of Stoboclo and Osenvelt is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA.
This marks the third denosumab biosimilar to receive approval. The first denosumab biosimilar to launch will be Sandoz’s Jubbonti/Wyost, at the end of May. Celltrion’s product (and assuming Samsung Bioepis’ Ospomyv/Xbryk) should launch in June. At least three others could potentially launch this year.
Furthermore, Amneal Biosciences announced that its own denosumab biosimilar applications have been accepted for review by the FDA. This could mean an approval in Q1 2026. Amneal is partnered with mAbxience (its majority stakeholder is Fresenius Kabi) on this denosumab biosimilar candidate.
In Other Celltrion Biosimilar News…The company announced that it is beginning its phase 1 trial of a new subcutaneous form of trastuzumab, based on its biosimilar Herzuma. The comparator drug is Genentech’s Herceptin Hylecta, which is also delivered subcutaneously. This development follows Celltrion’s successful commercialization of its subcutaneously injectable form of infliximab (Zymfentra).
