Sandoz, a Novartis division, has announced that its biologics licence application for its proposed biosimilar denosumab has been accepted by the US Food and Drug Administration (FDA).
The application comprises all indications covered by Amgen’s reference medicines, Prolia and Xgeva, including osteoporosis in postmenopausal women and in men at an increased risk of fractures.
In the US alone, more than ten million adults over the age of 50 are estimated to have osteoporosis, a condition that weakens bones, making them fragile and more likely to break.
Postmenopausal women are disproportionately impacted by the condition and account for around 80% of the estimated US osteoporosis patient population, with one in two of these women predicted to have an osteoporosis-related fracture in their lifetimes.
A human monoclonal antibody, denosumab, is designed to decrease the production and activity of the cells involved in breaking down bone tissue, resulting in a reduction of bone loss and the likelihood of fractures and other serious bone conditions.
“In addition to being an important medicine for cancer of the bone, denosumab is critical in the treatment of osteoporosis and potential prevention of osteoporosis-related fractures that so many women over 50 are at risk of,” said Keren Haruvi, president of Sandoz and head of North America.
Sandoz’s US application includes data from its phase 1/3 ROSALIA study, which confirmed the proposed biosimilar denosumab matched the reference medicine in women with postmenopausal osteoporosis.
“We are proud to be among the first to submit a biologics licence application for a denosumab biosimilar as, if approved, it could increase patient access to an affordable, high-quality, potentially disease-modifying treatment across the US, while also delivering savings for healthcare systems,” Haruvi said.
Sandoz, which has a total of eight marketed biosimilars and over 15 in various stages of development, received a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) last month for a citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab).
The recommendation comprises all indications covered by the reference medicine, including Crohn’s disease, plaque psoriasis, ulcerative colitis, rheumatoid arthritis and uveitis.