MedCity News March 5, 2024
Frank Vinluan

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies.

A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products.

The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
FDA Approves Third Tocilizumab Biosimilar
The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its Clinical Decision Support Guidance
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown

Share This Article