Pharmaceutical Technology

FDA approves the first Tysabri biosimilar for MS and Crohn’s disease

The Sandoz biosimilar, Tyruko, was approved by the US FDA for all indications of Tysabri based on Phase I and III data.

The first biosimilar of Biogen’s Tysabri (natalizumab) is set to hit the market with approval from the US Food and Drug Administration (FDA).

Sandoz’s Tyruko has been approved for all multiple sclerosis (MS) settings where Tysabri is currently used, including relapsing-remitting MS, clinically isolated syndrome (CIS), and active secondary progressive disease, in addition to Crohn’s disease.

Biosimilar sales have generated a record profit for Sandoz, with the company reporting $2.4bn in sales in Q2 2023. Sandoz has previously announced plans to launch four high-profile biosimilars in the next few years to further expand its biosimilar portfolio as it breaks free from its parent company Novartis by the end of 2023.

Tysabri is an anti-α4 integrin monoclonal antibody disease-modifying therapy (DMT), which was first approved by the FDA in 2004. Biogen reported sales of $1.2bn in sales from MS therapies, including $483.1m with Tysabri, in Q2 2023.

The MS market is primed for growth, generating $29.8bn by 2030 in the seven major markets (US, France, Germany, Italy, Spain, UK, Japan), as per GlobalData estimates. Roche’s Ocrevus (ocrelizumab) and Novartis’ Kesimpta (ofatumumab) are expected to be market leaders in the space.

GlobalData is the parent company of Pharmaceutical Technology.

The FDA approval was based on Phase I/Phase III trial (NCT04115488) data, showing non-inferiority to Tysabri. Sandoz has also filed for Tyruko’s approval in Europe, with the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) already providing a positive opinion for EU approval.

Tyruko was originally developed by Polpharma Biologics, with Sandoz acquiring the exclusive global commercialisation rights from the former in 2019. As per the agreement, Polpharma is responsible for the development, manufacturing, and supply of the drug, whilst Sandoz bears responsibility for distribution and commercialisation.

The dosing frequency and administration for Tyruko is the same as Tysabri, with 300mg of the drug injected intravenously every four weeks, with each infusion lasting an hour.