Ensuring familiarity with the area
Pharmacy teams and individuals planning to use denosumab biosimilar for osteoporosis should prepare carefully. Read the following to understand where denosumab 60mg 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.
Product characteristics
Prolia (Amgen) is the denosumab 60mg reference product. Refer to the product information for the licensed indications and full prescribing advice. Prolia is available as a 60mg pre-filled syringe.
Incoming changes with denosumab
It is anticipated denosumab will lose patent exclusivity November 2025.
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 December 2025, the following denosumab 60mg biosimilar products are licensed in the UK, and as such may be launched following loss of patent exclusivity.
Bildyos (Science Pharma)
Product information available via MHRA website
Conexxence (Fresenius Kabi)
Product information available via MHRA website
Evfraxy (Biosimilar Collaborations Ireland)
Product information available via MHRA website
Izamby (Mabxience Research)
Product information available via MHRA website
Jubbonti (Sandoz)
Product information available via MHRA website
Junod (Gedeon Richter)
Product information available via MHRA website
Kefdensis (Genus pharmaceuticals Ltd)
Product information available via MHRA website
Obodence (Samsung Bioepis)
Product information available via MHRA website
Osvyrti (Accord Healthcare)
Product information available via MHRA website
Ponlimsi (Teva)
Product information available via MHRA website
Stoboclo (Celltrion)
Product information available via MHRA website
Zadenvi (Zentiva Pharma)
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 December 2025, the following biosimilars have been approved in the EU.
- Denosumab Intas 60mg pre-filled syringe
- Rolcya (Sandoz) 60mg pre-filled syringe
- Bildyos (Henlius Europe) 60mg vial
As of December 2025, the following biosimilars have been issued positive opinions (recommending the granting of a marketing authorisation).
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.
The primary care sector will need to consider local formulary status and prescribing pathways.
Secondary care implementation checklist
Use our phase one implementation checklist to support planning.
Primary care 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 120mg biosimilar
We also have materials to support with the implementation of denosumab 120mg 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: Bildyos, Kefdensis, Ponlimsi. Updated with EMA development for Denosumab Intas, Bildyos
- Updated with new licensed products: Conexxence, Junod, Zadenvi. Updated with EMA development for Rolcya, Acvybra, Kefdensis, Ponlimsi.
- Added link to MHRA guidance in Primary Care implementation checklist
- Removed osteoporosis from title
- Published
- Originally published