Ensuring familiarity with the area
Pharmacy teams and individuals planning to use golimumab biosimilar should prepare carefully. Read and understand the following to understand where golimumab is currently recommended for use.
National guidelines
Ensure you are familiar with:
- Golimumab for the treatment of psoriatic arthritis (NICE TA220)
- Golimumab for treating non-radiographic axial spondyloarthritis (NICE TA497)
- Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs (TA225)
- Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (NICE TA329)
- Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (NICE TA375)
Where NICE has recommended the reference product (‘the originator’), the same advice will apply to the biosimilar medicine.
Product characteristics
Simponi (Janssen-Cilag) is the golimumab reference product. Refer to the product characteristics (SPC) for the licensed indications and full prescribing advice. Simponi is available as:
Incoming changes with golimumab
It is anticipated that Simponi may lose patent exclusivity this year.
As of May 2025, the EMA is assessing two golimumab biosimilars; brand names currently unknown:
- AVTO5 (Advanz) – filed November 2024 with approval anticipated Q4 2025
- BAT2506 – filed February 2025
A NIHR (National Institute for Health and Care Research) Health Technology Briefing is available for AVT05 (Advanz).
Planning for implementation
We recommend the system starts planning for biosimilar golimumab.
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.
As golimumab is predominantly supplied through homecare, early engagement with homecare teams and providers is essential.
Implementation checklist
Use our phase one implementation checklist to support planning. Phase two checklist coming soon.
Patient information sheet
SPS will produce a patient information sheet that can be adapted locally. Coming soon.
Product specific advice
We will endeavour to provide additional information relating to key differences between biosimilar 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 provide background information on biologic and biosimilar medicines to support those new to the area or for those who would like to refresh their knowledge.
Understanding biological and biosimilar medicines
SPS resources on pipeline medicines
Be aware of information on pipeline ustekinumab biosimilars. Detail is available from: