The licence and supporting evidence for natalizumab biosimilar

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One licensed natalizumab biosimilar is available: Tyruko. Learn about the licensed indications and supporting evidence.

Licensed indications

Tyruko is licensed in adults for the treatment of highly active relapsing remitting multiple sclerosis (RRMS) in patients:

  • with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or
  • with rapidly evolving severe relapsing remitting multiple sclerosis (RES) defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.

These are the same licensed indications, in adults, as the originator product Tysabri.

Evidence supporting safety and efficacy

The safety profile and immunogenicity of the natalizumab biosimilar (Tyruko) and the reference product are similar.

Clinical trial data

A randomised trial in 264 patients with RRMS showed that the natalizumab biosimilar (Tyruko) was clinically equivalent to the reference product when 300mg was given by intravenous infusion every 4 weeks for 44 weeks.

Primary outcome

The primary outcome was the cumulative number of new active brain lesions on MRI over 24 weeks.  Equivalence was defined as a mean difference of +/- 2.1 lesions.  At week 24 the mean difference in the cumulative number of new active lesions between treatment groups was 0.17 with 95% confidence interval ranging between -0.61 to +0.94.

Secondary outcomes

Annualised relapse rate (ARR) and change from baseline Expanded Disability Status Scale score (EDSS) were secondary clinical end points.  ARR was similar at 24 weeks (biosimilar natalizumab 0.21; reference natalizumab 0.15) and 48 weeks (biosimilar natalizumab 0.17; reference natalizumab 0.13).  At baseline EDSS scores were similar between the groups. Changes from baseline were minimal and similar in both groups at 24 weeks and 48 weeks.

Anti-JCV antibodies

Blood samples for anti-JCV antibodies were collected at screening, weeks 24 and 48 and evaluated using a cell-based validated assay.  At baseline, no patient had a JCV-positive index greater than 1.5 and the proportion of anti-JCV positive patients was similar in both groups throughout the study period.  At week 24 and week 48 the proportion of patients reporting a JCV-positive index greater than 1.5 was similar.  No patients with progressive multifocal leukoencephalopathy (PML) were identified during the treatment period (48 weeks) or follow up period of 24 weeks after the last treatment. 

NICE recommendations

NICE guidance published in 2007 recommends natalizumab (branded or biosimilar) as an option only for the treatment of RES.

 

Update history

  1. Minor change to NICE recommendations
  1. Published