Preparing to use ustekinumab biosimilar

Ensuring familiarity with the area

Pharmacy teams and individuals planning to use ustekinumab biosimilar should prepare themselves carefully. Make sure you are aware of, and where necessary read and understand, the following.

National guidelines

Ensure you are familiar with:

• Ustekinumab for the treatment of adults with moderate to severe psoriasis (NICE TA180) 
• Ustekinumab for treating active psoriatic arthritis in adults (NICE TA340)
• Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people (NICE TA455) 
• Ustekinumab for moderately to severely active Crohn’s disease after previous treatment in adults (NICE TA456)
• Ustekinumab for treating moderately to severely active ulcerative colitis (NICE TA633)

The same guidance will apply to the biosimilar where NICE has already recommended the reference biological medicine 

National commissioning policies

Ensure you are familiar with NHS England clinical commissioning policies:

• Ustekinumab for refractory Crohn’s disease in pre-pubescent children
• Commissioning medicines for children in specialised services

Incoming changes with ustekinumab

Ustekinumab was initially exclusively marketed in the UK under the brand name Stelara (Janssen). Stelara lost its patent exclusivity on 19th July 2024. For further information on patents and loss of exclusivity see our articles on Understanding biosimilar and generic market entry (SPS page).

NHS Framework awards

The initial national ustekinumab contract is coming to an end and a new contract is planned from September 2026. Two additional biosimilar ustekinumab products will be available, Otufli (Fresenius Kabi) and Yesintek (Biosimilar Collaborations Ireland).

The Medicines Procurement and Supply Chain web catalogue provides information about the products that are available on NHS contracts in England. Further detail should be obtained from your Regional Pharmacy Procurement Specialist team.

Available biosimilars

The following biosimilar ustekinumab products are available to use within the NHS framework.

Otulfi (Fresenius Kabi)

Available as vials and pre-filled syringes. Product information available via EMC website. Pre-filled pens awaiting a licence within the UK.

Pyzchiva (Sandoz)

Available as vials, pre-filled syringes and pre-filled pens. Product information available via EMC website.

Steqeyma (Celltrion)

Available as vials, pre-filled syringes and pre-filled pens. Product information available via EMC website.

Uzpruvo (Stada, Thornton & Ross)

Available as vials and pre-filled syringes. Product information available via EMC website.

Wezenla (Amgen)

Available as vials, pre-filled pens and pre-filled syringes. Product information available via EMC website.

Yesintek (Biosimilar Collaborations Ireland)

Will be available as vials, pre-filled syringes and pre-filled pens. Product information available via MHRA website.

Product specific advice

Read our article covering licenced indications, supporting evidence and differences between the ustekinumab biosimilars that are available for use in the NHS.

Developing an implementation plan

Developing an implementation plan will require working collaboratively across integrated care systems. This will include work within pharmacy as well as with prescribing clinicians, specialist nurses, business managers, finance and contracting teams, pharmaceutical industry and homecare providers.

Identify patients receiving ustekinumab

This work will need to be undertaken with clinicians. You should understand the number of patients in your organisation receiving ustekinumab, indications, formulations and route of supply.

Identify patients eligible for ustekinumab biosimilar

Continue working with clinicians to identify the opportunity for biosimilar introduction. Identify patients suitable for ustekinumab biosimilar as well as those for whom it would be clinically inappropriate to use the biosimilar.

Ensure use in local pathway of care

To ensure ustekinumab biosimilar can be used within a local care pathway, you should consider several factors across the integrated care system.

Service capacity

Extra capacity may be required to support additional work associated with the biosimilar introduction so that existing services are not adversely affected.

Consider the potential effects for:

• operational aspects associated with changing homecare provider
• the number of clinic visits, and the ability to deliver services safely
• the operational impact for clinicians and specialist nurses on other related clinical services
• pharmacy capacity to dispense and store the medicine
• pharmacy capacity to support, implement and monitor the introduction of a biosimilar

Processes

Consider the need to:

• engage and involve homecare leads early to understand how many patients are being treated, delivery frequencies and number of patients receiving ongoing nurse support
• engage with the chosen homecare provider to determine if an efficient transfer of patients between brands is possible
• establish processes with clinicians and patients to ensure shared decision making is possible supported by written materials, information sessions, education and patient alert cards
• ensuring staff responsible for implementation prepare themselves using any necessary materials, including information sessions and education
• ensure a workable process for actions to take when reviewing, switching and discontinuing treatments in line with the national recommendations for these medicines
• obtain patient consent, a template patient information sheet is available from SPS

Savings

Ensure savings can be used effectively to offset costs, incentivise change and improve patient care.

Implementation checklist

SPS has produced a checklist to support implementation planning.

• Ustekinumab Implementation ChecklistOpens in a new window · Word · 36 KB

SPS resources on use of biosimilars

SPS has produced materials to help understand the background to biological and biosimilar medicines in general.

SPS resources on pipeline medicines

Be aware of information on pipeline ustekinumab biosimilars. Detail is available from:

• Our annual planning advice for new medicines (SPS page)

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