The European approval for Tyruko comes a month after the US Food and Drug Administration (FDA) approval. The biosimilar was approved for all multiple sclerosis (MS)-related settings where Biogen’s Tysabri is currently used, including relapsing-remitting MS, clinically isolated syndrome (CIS), and active secondary progressive disease, in addition to Crohn’s disease.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion of the drug back in July. This was based on the clinical and preclinical data, including results from the Phase I and Phase III Antelope (NCT04115488) studies, which demonstrated that Tyruko was non-inferior to Tysabri.
Tysabri is an anti-alpha4 integrin monoclonal antibody disease-modifying therapy (DMT), which was first approved by the FDA in 2004. MS is a high-grossing indication for Biogen having generated $1.2bn in Tysabri sales in Q2 2023. Tysabri was responsible for generating about half of the MS therapy revenue in that period, pulling in $483.1m in global sales, as per Biogen’s financials.
GlobalData forecasts that the MS market is primed for growth and is expected to generate $29.8bn by 2030 in the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan). Roche’s Ocrevus (ocrelizumab) and Novartis’ Kesimpta (ofatumumab) are expected to be market leaders in the space, bringing in sales of $6.3bn and $4.5bn in 2030, respectively.
GlobalData is the parent company of Pharmaceutical Technology.
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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.