Remove condition osteoporosis
article thumbnail

FDA Accepts Biologics License Application for Proposed Denosumab Biosimilar

Drug Topics

The drug, manufactured by Sandoz, will treat conditions including osteoporosis in postmenopausal women

FDA 187
article thumbnail

FDA approves first biosimilars to Prolia and Xgeva

The Checkup by Singlecare

Osteoporosis and bone density conditions are common in the U.S.—the According to a 10-year review of clinical studies , it is a highly effective anti-osteoporosis therapy for patients at high risk of fracture. Like Prolia, Jubbonti must be given as an injection by healthcare providers every six months.

FDA 98
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Sandoz biologics license application for denosumab accepted by FDA

Drug Store News

Denosumab is indicated for treating variety of conditions, such as osteoporosis in postmenopausal women.

FDA 98
article thumbnail

Osteoporosis treatment options – down to the bare bones

pharmaphorum

It is World Osteoporosis Day this month, and Ben Hargreaves takes a look at what treatment options look like for patients living with the disease. Osteoporosis is a condition that causes bones to become weak and fragile, making them more likely to break due to a fall or even something as minor as a sudden movement.

article thumbnail

US FDA accepts Sandoz’s BLA for biosimilar denosumab

Pharmaceutical Technology

Denosumab will be used to treat several conditions, including osteoporosis in postmenopausal women and in men with high fractures risk, treatment-induced bone loss. This results in bone loss reduction and the likelihood of fractures and other serious conditions related to bones.

FDA 52
article thumbnail

NICE ends UK access disparity to osteoporosis drug Evenity

pharmaphorum

NICE has reversed its stance on UCB and Amgen’s severe osteoporosis therapy Evenity, saying out can be prescribed on the NHS for women with the disease in England and Wales who are at high risk of fractures. ” “Osteoporosis is one of the most urgent challenges to people living well in later life,” he added.

article thumbnail

EMA accepts Sandoz’s marketing applications for biosimilar denosumab

Pharmaceutical Technology

The MAAs include all indications covered by the Xgeva (denosumab) and Prolia (denosumab) reference medicines to treat conditions such as osteoporosis in postmenopausal women. Other conditions include the prevention of skeletal-related complications in cancer that has spread to the bones, as well as treatment-induced bone loss.