Sandoz, a Novartis division, has announced that its biosimilar Tyruko (natalizumab-sztn) has been approved by the US Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS).

The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is now the first FDA-approved biosimilar for this patient population.

A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of MS,” said Paul Lee, director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research.

Tyruko, which is administered as an injection, is approved as a monotherapy to treat all indications covered by Tysabri for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn’s disease in adults.

Over 1 million people in the US are affected by MS, a disabling and unpredictable neurological disease that disrupts communication between the brain and other parts of the body.

Relapsing forms of MS account for the majority of MS cases and are characterised by episodes of new or worsening signs or symptoms followed by periods of recovery.

The FDA's decision on Tyruko was supported by evidence confirming similarity of the biosimilar with the reference biologic in terms of efficacy, safety and immunogenicity.

Keren Haruvi, president of North America at Sandoz, said: “Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”

Sandoz and Polpharma Biologics signed a global commercialisation agreement for the biosimilar in 2019. As part of the deal, Polpharma Biologics will develop, manufacture and supply the biosimilar, while Sandoz will commercialise and distribute the biosimilar in all markets through an exclusive global licence.

Michael Soldan, chief executive officer of Polpharma Biologics Group, said: “We are delighted that the FDA’s approval of Tyruko means clinicians will soon have access to an affordable treatment that can change the lives of people with relapsing MS. We will support our partner Sandoz to bring Tyruko to patients as quickly as possible.”

Reference：
https://www.pmlive.com/pharma_news/sandozs_tyruko_approved_by_fda_as_first_biosimilar_for_relapsing_multiple_sclerosis_1496800