Scope
All denosumab 60mg biosimilar products licensed in the UK in November 2025 are discussed within this article. Denosumab 60mg biosimilars may be launched following loss of patent exclusivity anticipated November 2025.
NHS Trusts should be guided on choice of biosimilar products by NHS Framework awards.
Licensed indications
Denosumab 60mg biosimilars (Conexxence, Evfraxy, Izamby, Jubbonti, Junod, Obodence, Osvyrti, Stoboclo, Zadenvi) are approved for all reference product (Prolia) indications.
Formulations
Denosumab 60mg biosimilar products are available only as a pre-filled syringe presentation as is the reference product Prolia.
Evidence supporting safety and efficacy
The clinical efficacy, safety profile and immunogenicity of denosumab 60mg biosimilars and Prolia, the reference product, are similar. For each product, one comparative study in post menopausal woman with osteoporosis were submitted to support the biosimilar licence application. We provide summaries of these studies, further details are available in the public assessment reports.
Extrapolation of data to other indications
Denosumab 60mg biosimilars are considered highly similar to the reference product (Prolia) based on results of clinical trials in post menopausal woman with osteoporosis. The osteoporosis population was selected as it is the most common cohort that denosumab 60mg is prescribed for. The biosimilar licence is extrapolated to additional indications already approved (licensed) for the reference product (Prolia).
Conexxence (Fresenius Kabi)
An unpublished phase 3, double-blind, randomised, efficacy and safety study evaluated 553 postmenopausal women with osteoporosis. It demonstrated Conexxence is as effective as Prolia at increasing bone mineral density in the spine. After one year, bone mineral density increased by around 5.7% in women who received Conexxence and 5.1% for Prolia (confidence interval not reported). The safety profiles are considered comparable between Conexxence and the reference product.
Evfraxy (Biosimilar Collaborations Ireland)
A published phase 3, double-blind, randomised, efficacy and safety study study demonstrated similarity in clinical effectiveness of Evfraxy with Prolia. The safety profiles are considered comparable between Evfraxy and the reference product.
Izamby (Mabxience Research)
An unpublished phase 3, double-blind, randomised, efficacy and safety study evaluated 558 postmenopausal women with osteoporosis. It demonstrated Izamby is as effective as Prolia at increasing bone mineral density in the spine. After one year, bone mineral density increased by around 5.5% in women who received Jubbonti and 5.3% for Prolia. The safety profiles are considered comparable between Izamby and the reference product. I
Jubbonti (Sandoz)
An unpublished phase 3, double-blind, randomised, efficacy and safety study evaluated 463 postmenopausal women with osteoporosis. It demonstrated Jubbonti is as effective as Prolia at increasing bone mineral density in the spine. After one year, bone mineral density increased by around 5.0% in both women who received Jubbonti and Prolia. The safety profiles are considered comparable between Jubbonti and the reference product.
Junod (Gedeon Richter)
An unpublished phase 3, double-blind, randomised, efficacy and safety study evaluated 473 postmenopausal women with osteoporosis. It demonstrated Junod is as effective as Prolia at increasing bone mineral density in the spine. After one year, bone mineral density increased by around 4.9% in women who received Junod and 4.6% for Prolia. The safety profiles are considered comparable between Junod and the reference product.
Obodence (Samsung Bioepis)
A phase 3, double-blind, randomised, efficacy and safety study demonstrated similarity in clinical effectiveness of Obodence with Prolia. Safety profiles are considered comparable between Obodence and the reference product.
Osvyrti (Accord Healthcare)
An unpublished phase 3, double-blind, randomised study of 522 menopausal women with osteoporosis demonstrated similarity in clinical efficacy between Osvyrti and Prolia. After one year, bone mineral density in the spine increased by around 6% in both women who received Osvyrti and Prolia. The safety profiles are considered to be comparable between Osvyrti and the reference product.
Stoboclo (Celltrion)
A phase 3, double-blind, randomised, efficacy and safety study demonstrated similarity in clinical efficacy between Stoboclo and Prolia. Safety profiles are considered comparable between Stoboclo and the reference product.
Zadenvi (Zentiva)
An unpublished phase 3, double-blind, randomised, efficacy and safety study evaluated 558 postmenopausal women with osteoporosis. It demonstrated similarity in clinical efficacy between Zadenvi and Prolia. After one year, bone mineral density in the spine increased by around 5.5% in women who received Zadenvi and 5.3% for received Prolia. Safety profiles remained comparable between Zadenvi and the reference product.
Differences between brands
Comparison of excipients and shelf life between denosumab biosimilars and the reference products (Prolia).
Administration
All available denosumab 60mg products should be administered by an individual who has been adequately trained in injection techniques. The design of the syringe may differ between the biosimilar and Prolia. Existing patients prescribed denosumab 60mg should be made aware of this during any switch to a biosimilar.
Sodium content
All denosumab 60mg products for subcutaneous administration can be considered sodium free (Evfraxy, Conexxence, Izamby, Jubbonti, Junod, Obodence, Osvyrti, Stoboclo, Zadenvi).
Other excipients of interest
There are no significant differences in relation to excipients of interest between the reference product and the currently approved biosimilar products. Refer to individual Summary of Product Characteristics for further information on excipients and any variations between products.
Sorbitol
All available denosumab biosimilars contain 46mg sorbitol (Izamby, Osvyrti, Junod, Zadenvi) or 47mg sorbitol (Conexxence, Evfraxy, Jubbonti, Obodence, Prolia, Stoboclo) in each 60mg pre-filled syringe.
Polysorbate 20
All available denosumab products contain 0.1 mg of polysorbate 20 in each syringe. Polysorbates may cause allergic reactions.
Latex
The reference product Prolia and biosimilars Evfraxy, Izamby, Jubbonti, Junod, Obodence, Osvyrti, Stoboclo and Zadenvi are latex free.
Presence of latex is currently unknown for Conexxence.
Needle characteristics
All denosumab 60mg preparations use small gauge needles, 27G (0.413mm) or 29G (0.337mm), and the small differences are unlikely to cause a difference in practice.
The following densomab 60mg products have 27G needles:
- Junod pre-filled syringe
- Osvyrti pre-filled syringe
- Prolia pre-filled syringe
- Stoboclo pre-filled syringe
The following denosumab 60mg products have 29G needles:
- Conexxence pre-filled syrige
- Evfraxy pre-filled syringe
- Izamby pre-filled syringe
- Jubbonti pre-filled syringe
- Obedence pre-filled syringe
- Zadenvi pre-filled syringe
Storage and stability
Shelf life
There is some variation in the shelf life between products:
- 2 years: Izamby, Osvyrti, Zadenvi
- 3 years: Conexxence, Evfraxy, Jubbonti, Junod, Obedence
- 4 years: Prolia, Stoboclo
Storage
All denosumab prefilled syringe products should be stored in a refrigerator (2°C to 8°C). Remove denosumab prefilled syringes for subcutaneous administration from the refrigerator before administration to allow the product to reach room temperature.
Further resources
SPS have further resources on biosimilars and biosimilar denosumab 60mg.