Ustekinumab biosimilars: real-world and switching evidence
What the evidence shows
- Studies found2 studies: the trial built for the FDA interchangeability decision on Wezlana, and a Canadian bowel disease cohort from routine care.
- The trialPsoriasis patients on Stelara were switched to Wezlana and back every 12 weeks for six months, or kept on Stelara. Drug levels, psoriasis control, side effects and antibodies were the same in both groups. Wezlana became the first interchangeable ustekinumab biosimilar in October 2023.
- Routine careIn Montreal, 81 patients with Crohn disease or colitis were moved from Stelara to a biosimilar under a mandated programme. Six months later 95 in 100 were still on it and remission rates had not changed, even though most had needed higher doses of Stelara before the switch.
- Products with evidenceWezlana. The Canadian cohort does not name its biosimilar. No published switching study yet in this register for the other nine ustekinumab biosimilars or the Japanese products.
- What is missingNo study from India or the Gulf. No study in children. Nothing beyond six months in routine care.
Studies
Trials with repeated switching
Patients switched between Stelara and the biosimilar more than once, with a control group that stayed on Stelara. FDA interchangeability decisions rest on this design.
| Study | Disease | Switch | Products | Patients switched | Follow-up | What the authors report |
|---|---|---|---|---|---|---|
| Blauvelt 2026 Br J Dermatol 2026 (advance article, ljag218) Multicentre, North America and Europe | Plaque psoriasis | Repeated switches between reference and biosimilar every 12 weeks from week 28 to week 52 (three switches) | Wezlana | 228 | 52 weeks (64 weeks on study) | Pharmacokinetics, psoriasis control, safety and immunogenicity similar after repeated switching and continued reference use; the authors conclude the results support interchangeability. FDA interchangeability granted October 2023. |
Pharmacokinetics, psoriasis control, safety and immunogenicity similar after repeated switching and continued reference use; the authors conclude the results support interchangeability. FDA interchangeability granted October 2023.
No study matches this selection.
Real-world cohorts
Switches carried out in hospitals and national programmes, with outcomes taken from registries and patient records.
| Study | Disease | Switch | Products | Patients switched | Follow-up | What the authors report |
|---|---|---|---|---|---|---|
| Kritzinger 2025 World J Gastroenterol 2025;31(48):114355 McGill University Health Centre, Montreal, Canada (single centre) | Crohn disease (85%) and ulcerative colitis | Originator to biosimilar (non-medical, mandated) | not named | 81 | 24 weeks | 96.3% still on the biosimilar at 12 weeks and 95% at 24 weeks; clinical remission 87%, 85.9%, 84.3% and 92.7% at the four time points (no significant change); CRP, haemoglobin, albumin and faecal calprotectin unchanged; all who stopped had needed dose escalation of the originator and prior biologic therapy. |
96.3% still on the biosimilar at 12 weeks and 95% at 24 weeks; clinical remission 87%, 85.9%, 84.3% and 92.7% at the four time points (no significant change); CRP, haemoglobin, albumin and faecal calprotectin unchanged; all who stopped had needed dose escalation of the originator and prior biologic therapy.
No study matches this selection.
Switching evidence is what regulators, tender committees and formulary boards ask for before a change of product. EvySaif prepares interchangeability and switching dossiers and designs real-world studies for biosimilar programmes. Regulatory strategy consulting
Sources
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