The Food and Drug Administration (FDA) accepted the Biologics license application (BLA) for a proposed biosimilar from Denosumab.
Denosumab is a rankings inhibitor that is approved under the brand name Prolia for the treatment of women after menopause with osteoporosis with high fracture risk. Increasing bone mass in men with osteoporosis with a high risk of fracture; to treat the osteoporosis induced by glucocorticoid in men and women with a high risk of fracture; Increasing bone mass in men with a high risk of fracture that receive androgen withdrawal therapy for non -metastatic prostate cancer; And to increase the bone mass in women with high risk of adjuvant aromata seemmer therapy for breast cancer.
Denosumab is also indicated under the brand name XGEVA to prevent skeleton -related events in patients with several myelomas and in patients with bone metastases from solid tumors. To treat adults and skeletal ripens young people with a huge cell tumor of the bone, which cannot be reseted or if a surgical resection probably leads to severe morbidity; And for the treatment of hypercalcemia of malignancy strength for bisphosphonate therapy.
According to Sandoz, the BLA is supported by a comprehensive data package that contains data from the 1/3 Rosalia study (Klinicaltrials.gov Identifier: NCT03974100). In this study, 527 women with osteoporosis were accidentally received either biosimilar -denosumab or the reference product for up to 78 weeks of treatment after menopause. The results showed similarity between the 2 products in terms of pharmacokinetics, pharmacodynamics, effectiveness, security and immunogenicity.
“We are proud to be among the first to submit a BLA for a denosumab biosimilar because it increases the patient’s access to an affordable, high-quality, potentially illness-modifying treatment in the USA and at the same time providing savings on health systems,” said Keren Haruvi, President, Sandoz Inc. and Head of North America.
reference
Sandoz Biologic’s license application for proposed biosimilar Denosumab from US -FDA accepted. Press release. February 6, 2023.
This article originally appeared on MPR