Sandoz secures European approval for Tyruko biosimilar in MS treatment
26 September 2023 -

Generic and biosimilar medicines provider Sandoz, part of Swiss pharmaceutical company Novartis Pharma AG (SIX:NOVN) (NYSE:NVS), announced on Tuesday that the European Commission has granted marketing authorization for Tyruko (natalizumab), developed by Polpharma Biologics.

Tyruko was approved for all indications of the reference medicine, Tysabri (natalizumab), as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis (MS) in Europe.

Rebecca Guntern, European president at Sandoz, emphasized the importance of timely access to affordable, high-quality healthcare for individuals with MS, a chronic condition with no cure. The approval of Tyruko is seen as a significant step in making life-enhancing treatments more accessible to those living with MS in Europe.

MS is a chronic inflammatory and neurodegenerative disease that can significantly impact daily life. It typically involves periods of symptom relapses followed by remission phases. Early treatment with disease-modifying therapies (DMTs) can influence the course of MS and reduce future disability. However, access to DMTs varies, and the cost of MS medicines is often a barrier to access in many countries.

Sandoz entered into a global commercialization agreement with Polpharma Biologics in 2019, giving Sandoz exclusive rights to commercialize and distribute Tyruko in all markets while Polpharma Biologics retains responsibilities for development, manufacturing and drug substance supply.