Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
Biosimilars Deals 2023
Biosimilars Deals 2024
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Trade Marks

Amgen High Concentration PFS Xgeva® (denosumab) Approved by UK MHRA in 30 Days under New International Recognition Procedure

Feb 29, 2024

On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe.  This Xgeva PFS product is a high concentration product which is a line extension of the original Xgeva® sold as a vial product containing 120mg solution for injection. 

This is the first product to be authorised by the MHRA via the new International Recognition Procedure (IRP) introduced in January this year.    

The IRP allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.  In fast-tracking the authorisation of the new Xgeva® high concentration formulation, the MHRA considered a positive opinion issued by the European Medicines Agency on 25 January 2024.