Ensuring familiarity with the area
Pharmacy teams and individuals planning to use denosumab biosimilar for bone metastases in advanced cancer or giant cell tumours of the bone should prepare carefully. Read the following to understand where denosumab 120mg is currently recommended for use.
National guidelines
Ensure you are familiar with:
Where NICE has recommended the reference product (‘the originator’), the same advice will apply to the biosimilar medicine. Ensure you are familiar with local funding arrangements for denosumab 120mg.
Denosumab is not routinely commissioned for giant cell tumours of the bone as it is awaiting NICE TA publication for this indication. Ensure you are familiar with local treatment pathways and funding arrangements if denosumab 120mg is prescribed for this indication in your organisation.
Product characteristics
Xgeva (Amgen) is the denosumab 120mg reference product. Refer to the product information for the licensed indications and full prescribing advice. Xgeva is available as 120mg vial and a 120mg pre-filled syringe.
Incoming changes with denosumab
It is anticipated that denosumab will lose patent exclusivity November 2025.
Denosumab 120mg biosimilars will be available as a vial formulation; a denosumab 120mg biosimilar pre-filled syringe may also be expected.
NHS Contract
We will provide more detailed information about the products that will be available on NHS contract in England in due course.
Licensed biosimilars
As of November 2025, the following denosumab 120mg biosimilar products are licensed in the UK, and as such may launch following loss of patent exclusivity.
Bomyntra (Fresenius Kabi) vial and pre-filled syringe
Product information available via MHRA website
Denbrayce (Mabxience Research) vials
Product information available via MHRA website
Enwylma (Zentiva Pharma) vials
Product information available via MHRA website
Jubereq (Accord Healthcare) vials
Product information available via MHRA website
Osenvelt (Celltrion) vials
Product information available via MHRA website
Vevzuo (Biosimilar Collaborations Ireland) vials
Product information available via MHRA website
Wyost (Sandoz) vials
Product information available via MHRA website
Xbryk (Samsung Bioepis) vials
Product information available via MHRA website
Yaxwer vials (Gedeon Richter) vials
Product information available via MHRA website
These products are also approved or have a positive opinion in the EU.
In development
The EMA is in the process of assessing further biosimilars; plans for filing in the UK are currently unknown. As of November 2025, the following biosimilars have been approved.
Planning for implementation
We recommend organisations start planning for implementation of best value denosumab product.
Pharmacy will need to work collaboratively across the integrated care systems to plan for implementation and identify potential barriers. This will include collaboration with prescribing clinicians, specialist nurses, business managers, finance and contracting teams, pharmaceutical industry and homecare providers.
Early engagement with homecare teams and providers is essential.
Implementation checklist
Use our phase one implementation checklist to support planning.
Patient Information Sheet
SPS has produced a patient information sheet that can be adapted locally.
Product specific advice
We will provide additional information relating to key differences between denosumab 120mg products as soon as possible. Register with SPS and opt in to our weekly email to receive updates on this article and other new biosimilar resources.
SPS resources on use of biosimilars
We have materials to help understand the background to biological and biosimilar medicines in general.
Understanding biological and biosimilar medicines
SPS resources on denosumab 60mg biosimilars
We also have materials to support with the implementation of denosumab 60mg biosimilar.
SPS resources on pipeline medicines
Be aware of information on pipeline aflibercept biosimilars. Detail is available from:
Update history
- Updated with new licensed products: Bomyntra, Enwylma, Yaxwer.
- Published