Sandoz's Tyruko (natalizumab-sztn) gains FDA approval as first biosimilar for relapsing MS
25 August 2023 -

Generic and biosimilar medicines provider Sandoz, part of Swiss pharmaceutical company Novartis Pharma AG (SIX:NOVN) (NYSE:NVS), said on Friday that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn).

Dveloped by Polpharma Biologics, Tyruko is approved to treat all indications covered by the reference medicine Tysabri (natalizumab), offering a new option for managing relapsing forms of multiple sclerosis (MS) and Crohn's disease in adults.

It is the first and only FDA-approved biosimilar for relapsing forms of MS.

The FDA's approval was based on clinical studies which demonstrated Tyruko's parallel efficacy, safety and immunogenicity to the reference medicine.

Sandoz's collaboration with Polpharma Biologics, initiated in 2019, enables Tyruko's global commercialisation while Polpharma retains responsibility for its development and manufacturing. Sandoz holds the worldwide rights for distribution.