Rituximab biosimilars: real-world and switching evidence
What the evidence shows
- Studies found3 studies: the extension of the CT-P10 phase 3 trial, in which 109 rheumatoid arthritis patients moved from MabThera or Rituxan to Truxima, and two cohorts from routine care in rheumatology.
- Biggest studyItalian centres moved 181 patients with rheumatoid arthritis and other autoimmune rheumatic diseases from MabThera to a biosimilar, mostly Rixathon. Eight in ten were still on the biosimilar after a year and nearly the same after three.
- Products with evidenceRixathon, Truxima. No published switching study yet in this register for Ruxience, Riabni or the Indian products.
- What is missingNo study from India or the Gulf. Nothing in lymphoma or leukaemia, where most rituximab is used. No trial with repeated switching.
Studies
Trials and extensions with a single switch
Patients on MabThera in a trial were moved once to the biosimilar, usually at the half-way point, and followed alongside those who stayed.
| Study | Disease | Switch | Products | Patients switched | Follow-up | What the authors report |
|---|---|---|---|---|---|---|
| Shim 2019 Rheumatology (Oxford) 2019;58(12):2193-2202 Multinational, multicentre | Rheumatoid arthritis | Single switch, reference (US- or EU-sourced) to biosimilar | Truxima | 109 | 72 weeks | Mean change in DAS28-CRP from baseline at week 72 was -3.0, -3.0, -2.9 and -3.0 in the CT-P10, reference, US-reference-to-CT-P10 and EU-reference-to-CT-P10 groups; ACR responses and quality of life improvements similar; two patients developed new anti-drug antibodies in the extension; pharmacodynamics and safety similar across groups. |
Mean change in DAS28-CRP from baseline at week 72 was -3.0, -3.0, -2.9 and -3.0 in the CT-P10, reference, US-reference-to-CT-P10 and EU-reference-to-CT-P10 groups; ACR responses and quality of life improvements similar; two patients developed new anti-drug antibodies in the extension; pharmacodynamics and safety similar across groups.
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 |
|---|---|---|---|---|---|---|
| Gentileschi 2024 Ther Adv Musculoskelet Dis 2024;16 Multicentre, Italy (2018 to 2020) | Autoimmune rheumatic diseases (rheumatoid arthritis and connective tissue diseases) | Originator to biosimilar (non-medical) | Rixathon, Truxima | 181 | Mean 17 months | Retention on the biosimilar 81.5% at 12 months, 80.6% at 24 months and 77.4% at 36 months; retention higher with GP2013 than CT-P10 (p<0.001); no difference by diagnosis or sex. |
| Losinska 2023 Rheumatol Int 2023;43(5):881-888 Rheumatology outpatient clinic, Norway (single centre, 2018 to 2021) | Rheumatoid arthritis | Originator to biosimilar (non-medical, mandatory) | Rixathon | 88 | Up to 2 years | Overall drug survival 80.0% at one year and 57.7% at two years, higher in switched than in biosimilar-naive patients (p=0.036); most discontinuations were for remission (38.6%) or doctor decision (27.1%). |
Retention on the biosimilar 81.5% at 12 months, 80.6% at 24 months and 77.4% at 36 months; retention higher with GP2013 than CT-P10 (p<0.001); no difference by diagnosis or sex.
Overall drug survival 80.0% at one year and 57.7% at two years, higher in switched than in biosimilar-naive patients (p=0.036); most discontinuations were for remission (38.6%) or doctor decision (27.1%).
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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