Ensuring familiarity with the area
Pharmacy teams and individuals planning to use golimumab biosimilar should prepare carefully. Read 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
The patent for Simponi expired earlier this year; once golimumab biosimilars are licensed they can launch.
As of October 2025, the EMA is assessing two golimumab biosimilars:
- Gobivaz (Advanz) – filed November 2024 with positive opinion granted September 2025 (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 the best value biologic.
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 if a switch is planned.
Implementation checklist
Use our implementation checklists to support planning.
Patient information sheet
SPS has produced a patient information sheet that can be adapted locally.
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 golimumab biosimilars. Detail is available from:
Update history
- Patient information leaflet updated to version 2.
- Page updated with EU progress towards licensing; brand name added for Advanz product.
- Phase 2/3 checklists added to page.
- Patient information leaflet (for local adaption) added to page.
- Published