USFDA approves Sandoz’s Tyruko, developed by Polpharma Biologics, EMA’s approval expected

The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Approval of Tyruko by the European Medicines Agency is also expected imminently.

Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).

Tyruko was developed by Polpharma Biologics and will be made available to patients in the U.S. by its collaboration partner Sandoz. The new biosimilar is approved as a monotherapy to treat all indications covered by reference medicine Tysabri* (natalizumab) for relapsing forms of MS; including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease, and Crohn’s disease in adults.(1) Tyruko has the same intravenous (IV) dosage form, route of administration, dosing regimen and presentation as Tysabri*(1)- an established, highly effective anti-α4 integrin monoclonal antibody disease modifying treatment.

On 20 July 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tyruko, intended for the treatment of multiple sclerosis. The applicant for this medicinal product is Sandoz GmbH.

Tyruko will be available as 300 mg concentrate for solution for infusion. The active substance of Tyruko is natalizumab, a selective immunosuppressive medicinal product (ATC code: L04AA23). It acts mainly by preventing transmigration of mononuclear leukocytes into inflamed parenchymal tissue, reducing the inflammatory activity present in the central nervous system in patients with multiple sclerosis, it has been found on EMA’s web-site.

“Targeted therapies are the cornerstone of care for people with MS, but high medication prices are fueling access issues and healthcare expenditure. The need to address the rising costs of this devastating disease to patients and societies inspired the scientific teams at Polpharma Biologics to develop an efficacious MS biosimilar,” said Michael Soldan, Chief Executive Officer, Polpharma Biologics Group. “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.”

“Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

MS

MS is a progressive, chronic inflammatory and neurodegenerative disease of the central nervous system,(2) that can take a heavy toll on the lives of those affected and requires lifelong treatment. Broader access to more affordable treatment options is needed to reduce the substantial economic impact of MS to healthcare systems – per year, the disease costs the U.S. economy as much as $85.4 billion in the direct and indirect healthcare expenditure.(3)

The FDA granted approval based on a robust data package, including analytical, functional and clinical data. The approval is accompanied with the same labeling with safety warnings and a Risk Evaluation and Mitigation Strategy (REMS) as the reference medicine Tysabri*.(1) Upon launch Tyruko will be available through REMS program managed by our commercialization partner Sandoz.

Tyruko was developed by scientists at Polpharma Biologics and the company retains responsibility for manufacturing and supplying the drug substance. Sandoz has the rights to commercialize and distribute the biosimilar under an exclusive global license secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.