Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis
Novartis International AG / Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.
Integrated Phase I/lll study for proposed biosimilar denosumab to confirm matching efficacy, safety and immunogenicity with reference medicine
Holzkirchen, July 22, 2019 - Sandoz, a Novartis division and a global leader in biosimilars, today announced the first patient enrolled in ROSALIA, an integrated Phase I/III clinical study for its proposed biosimilar denosumab.
The study aims to confirm that the biosimilar matches the reference medicine in terms of pharmacokinetics, efficacy, safety, and immunogenicity in patients with postmenopausal osteoporosis.
Denosumab is indicated for treating a variety of conditions, such as osteoporosis in postmenopausal women, increased risk of fractures in men, treatment-induced bone loss, to prevent bone complications in cancer that has spread to the bone, and giant cell tumor of the bone,,,. The study will be conducted in osteoporosis as this is an adequately sensitive indication and representative of many patients who are treated with the medicine.
Approximately 200 million people worldwide suffer from osteoporosis, which results in 8.9 million fractures annually,. By 2050, hip fractures are projected to increase by 240% in women and 310% in men compared to 1990.
"People with the bone disease osteoporosis are more likely to fracture or break a bone, causing pain and restriction of mobility, which can be extremely debilitating," said Florian Bieber, Global Head of Development, Sandoz Biopharmaceuticals. "As we progress our development program for proposed biosimilar denosumab, we believe it gives patients hope for early and expanded access to advanced biologic medicines, which may change the course of their disease."