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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 Framework awards
    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 Framework awards

The Medicines Procurement and Supply Chain (MPSC) web catalogue provides information about products available on NHS England procurement frameworks. Further information on procurement arrangements is available in the SPS article series, Procurement of medicines and services for NHS secondary care (SPS page).

Denosumab is prescribed widely across both primary and secondary care settings. The scope of this article is not limited to NHS secondary care procurement frameworks and includes all UK-licensed denosumab 60mg biosimilars.

Licensed biosimilars

As of September 2026, the following denosumab 60mg biosimilar products are licensed in the UK: 

Acvybra (Dr Reddy’s)

Product information available via MHRA website

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 (Stada)

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

Other denosumab biosimilars are in development. Information will be added if UK regulatory filings are announced or products receive a UK licence.

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. Updated with licensed product Acvybra; new developments section streamlined.
  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