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Natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy

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2 Information about natalizumab

Marketing authorisation indication

2.1

Natalizumab originator (Tysabri, Biogen) and natalizumab biosimilar (Tyruko, Sandoz) are indicated 'as single disease-modifying therapy in adults with highly active relapsing–remitting multiple sclerosis (RRMS) for the following patient groups:

  • Patients with highly active disease despite a full and adequate course of treatment with at least one disease-modifying therapy (DMT)
    or

  • Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesion on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.'

Dosage in the marketing authorisation

Price

2.4

The list price for natalizumab originator is:

  • £1,130 per 300 mg/15 ml concentrate for solution for intravenous infusion vials (excluding VAT; BNF online, accessed February 2025).

  • £1,130 per 2 x 150 mg syringe for subcutaneous injection (company submission).

2.5

The list price for intravenous natalizumab biosimilar is £1,017 per 300 mg/15 ml concentrate for solution for infusion vials (excluding VAT; BNF online, accessed February 2025).

2.6

The companies that make natalizumab originator and natalizumab biosimilar have commercial arrangements. This makes natalizumab available to the NHS with a discount and it would have also applied to this indication if natalizumab had been recommended. The size of each discount is commercial in confidence.

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