EC approves Tyruko, first MS biosimilar in Europe

The European Commission (EC) granted marketing authorization for Tyruko (natalizumab), the first and only biosimilar multiple sclerosis drug, developed by Dutch company Polpharma Biologics.

Tyruko will be marketed by Sandoz, the generics and biosimilars subsidiary of Swiss pharma giant Novartis (NOVN: VX), which is due to be spun out on October 4.

The authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EC for the reference medicine Biogen’s (Nasdaq: BIIB) injectable Tysabri, global sales of which were $2.03 billion in 2022. The US Food and Drug Administration (FDA) also approved Tyruko last month.