Sandoz Receives EU Approval for Tyruko, the First and Only Biosimilar for Relapsing Multiple Sclerosis

According to the Zhixun Finance APP, Sandoz, the generic drug division of Swiss pharmaceutical giant Novartis (NVS.US), announced on Tuesday that it has received marketing authorization from the European Commission to commercialize and distribute Tyruko for the treatment of relapsing multiple sclerosis (MS) in the EU.

It is reported that multiple sclerosis is a chronic inflammatory and neurodegenerative disease of the central nervous system. Early treatment with DMT can alter the course of a person's multiple sclerosis and reduce future disability.

The company pointed out that Tyruko, the biosimilar developed by Polpharma Biologics, has been approved for all reference drug indications and is the first and only biosimilar in Europe for the treatment of relapsing multiple sclerosis (MS).

The authorization covers a single disease-modifying therapy (DMT) treatment for adults with highly active relapsing-remitting multiple sclerosis (RRMS), matching the indications of the EU-approved reference drug Tysabri.

It is understood that the EU's decision was based on substantial analytical characterization demonstrating biosimilarity between the biosimilar and the reference product, as well as confirmatory studies from Phase I and Phase III trials.

In response, Rebecca Guntern, President of Sandoz Europe, stated: "Multiple sclerosis is a chronic disease that currently has no cure, making timely access to affordable, high-quality healthcare particularly crucial. Today’s approval makes it easier for patients with multiple sclerosis in Europe to access the life-improving treatments they need, bringing us one step closer to alleviating the burden of this disease."

Previously, Sandoz and Polpharma Biologics entered into a global commercialization agreement for the biosimilar Tyruko in 2019. Under the terms of the agreement, Polpharma Biologics will continue to be responsible for the development, manufacturing, and supply of the active substance for Tyruko. Sandoz has the right to commercialize and distribute Tyruko in all markets through an exclusive global license.