Sandoz Launches TYRUKO® in US A Game-Changer as First Multiple Sclerosis Biosimilar

Sandoz, a global leader in affordable generic and biosimilar medicines, has announced the availability of TYRUKO® (natalizumab-sztn) in the US market. Developed in partnership with Polpharma Biologics, TYRUKO® holds the critical distinction of being the first and only US Food and Drug Administration (FDA) approved natalizumab biosimilar for the treatment of relapsing forms of multiple sclerosis (MS).

This launch represents a pivotal moment in the treatment landscape for MS, aiming to significantly reduce the economic burden on patients navigating this chronic, often debilitating disease.

Expanding Access Through Biosimilarity

TYRUKO® is approved by the FDA as a monotherapy (used alone) for all indications covered by the reference medicine, Tysabri® (natalizumab). This includes:

Relapsing Forms of Multiple Sclerosis (MS) in adults.
Moderately to Severely Active Crohn’s Disease in adults.

Keren Haruvi, President of Sandoz North America, highlighted the company’s commitment, stating, “As the only biosimilar available to treat multiple sclerosis in the US, TYRUKO® has an important opportunity to help people with MS navigate this disease in a way that is more cost effective.”

The availability of biosimilars is widely viewed by patient advocacy groups, such as the National MS Society, as a vital step in making essential medications more affordable, directly addressing the significant barrier of cost and access to care.

Safety Protocols: REMS and PML Risk

Like its reference product, natalizumab is associated with the risk of Progressive Multifocal Leukoencephalopathy (PML), a rare but serious opportunistic viral brain infection. Consequently, TYRUKO® is available only through a rigorous Risk Evaluation and Mitigation Strategy (REMS) program.

The REMS program mandates that all stakeholders—prescribers, infusion site healthcare providers, and patients—are fully informed about key risk factors for PML, including:

The presence of anti-JCV antibodies (John Cunningham Virus antibodies).
Longer treatment duration.
Prior immunosuppressant use.

The program strictly warns against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents in immunocompromised patients, and promotes the early diagnosis of PML and timely discontinuation of TYRUKO® if PML is suspected.

Strategic Partnerships for Development and Risk Management

This launch is the result of a 2019 global commercialization agreement between Sandoz and Polpharma Biologics. Under the agreement:

Polpharma Biologics retains responsibility for the development, manufacturing, and supply of the drug substance.
Sandoz holds the exclusive global license to commercialize and distribute TYRUKO® in all markets, including the US and the 14 European countries where it is already available.

To support the critical safety measures, Sandoz has partnered with Labcorp to offer a TYRUKO® JCV Testing Program at no cost to eligible patients, covering the cost of the anti-JCV antibody laboratory-developed test (LDT) essential for PML risk stratification.

Sandoz’s Growth Ambition

The launch of TYRUKO® reinforces Sandoz’s leadership position in the biosimilar space, which includes 11 marketed biosimilars globally and 27 assets in development. TYRUKO® is expected to be a key contributor to the company’s growth strategy and its stated ambition to be the #1 biosimilars provider in the US and a global leader in neurology treatments.