FDA grants first approval for multiple sclerosis biosimilar

Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.

FDA grants first approval for multiple sclerosis biosimilar

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. Tyruko (natalizumab-sztn) is a biosimilar to Tysabri (natalizumab) injection for adults with relapsing forms of MS.

Approval of Tyruko has been granted to Sandoz Inc. It is indicated for the following relapsing forms of MS:

  • Clinically isolated syndrome – a single, first occurrence of MS symptoms
  • Relapsing-remitting disease – in this type of MS, episodes of new neurological symptoms are followed by periods of stability
  • Active secondary progressive disease – following a relapsing-remitting course, patients experience gradual disability worsening with continued relapses.

This biosimilar is also indicated for adult patients with moderate to severe active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of tumour necrosis factor (TNF-α).

As the reference medicine, Tysabri is a highly effective anti-α4 integrin monoclonal antibody disease modifying treatment, according to Sanzoz.

With “nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse” Keren Haruvi, President North America for Sandoz Inc. stated. Haruvi added that Tyruko has the potential to extend the reach of natalizumab treatment for these patients and “fuel innovation through competition in the market”.

The biosimilar treatment is only available via a Risk Evaluation and Mitigation Strategy (REMS), due to the identified risk of the viral infection progressive multifocal leukoencephalopathy (PML).

In 2019, Sandoz entered into a global commercialisation agreement for Tyruko with Polpharma Biologics. Under the terms of the agreement, Polpharma Biologics will be responsible for development, manufacturing and supply of the active substance in Tyruko. An exclusive global license grants Sandoz the rights to commercialise and distribute it in all markets.

Developments in the biosimilar space

Earlier this month, Sandoz announced that it had filed for approval of its aflibercept biosimilar to treat wet macular degeneration.

Additionally, the company recently declared it is currently planning to action its proposed spin-off from Novartis on or around 4 October 2023. To prepare for this transition, in early June 2023, Sandoz announced it will move its HQ to Basel in Switzerland.

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