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Preparing to use denosumab 60mg biosimilar

Published Last updated See all updates
Topics: BiosimilarsDenosumab

Biosimilars of denosumab 60mg (Prolia) are available. We offer general information and implementation advice.

Contents

  1. Ensuring familiarity with the area
    1. National guidelines
    2. Product characteristics
  3. Changes with denosumab
    1. NHS Contract
    2. Licensed biosimilars
    3. In development
  5. Planning for implementation
    1. Secondary care implementation checklist
    2. Primary care implementation checklist 
    3. Patient Information Sheet
  7. SPS resources on use of biosimilars
    1. SPS resources on denosumab 120mg biosimilar
    2. SPS resources on pipeline medicines
  9. Update history

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.  

Changes with denosumab

Denosumab lost patent exclusivity in November 2025.

Denosumab 60mg biosimilars are available as a pre-filled syringe presentation. 

NHS Contract

The Medicines Procurement and Supply Chain web catalogue provides information about the products that are available on NHS contracts in England.

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.

As of December 2025, the following biosimilars have been issued positive opinions (recommending the granting of a marketing authorisation).

Planning for implementation

Organisations should plan for implementation of best value denosumab product. 

Pharmacy 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.

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

Biosimilar medicines are a type of biological medicine that offer the NHS opportunities to deliver better value for certain conditions

The licence and supporting evidence for denosumab 60mg biosimilars

Denosumab 60mg biosimilars are licensed. Learn about indications, formulations, supporting evidence and differences.

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 biosimilars. Detail is available from:

Update history

  1. Wording updated to reflect current situation.
  1. Updated with new licensed products: Bildyos, Kefdensis, Ponlimsi. Updated with EMA development for Denosumab Intas, Bildyos
  1. Updated with new licensed products: Conexxence, Junod, Zadenvi. Updated with EMA development for Rolcya, Acvybra, Kefdensis, Ponlimsi.
  1. Added link to MHRA guidance in Primary Care implementation checklist
  1. Removed osteoporosis from title
  1. Published
  2. Originally published