Polpharma Biologics announces FDA approval of Tyruko® - first and only approved biosimilar to Tysabri®* for relapsing forms of multiple sclerosis

Amsterdam, The Netherlands, August 25^th, 2023

Polpharma Biologics, an international biotech company dedicated to the development and manufacture of biosimilars, announced today that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko^® (natalizumab-sztn) - a new biosimilar for the treatment of relapsing forms of multiple sclerosis (MS). Approval of Tyruko^® by the European Medicines Agency is also expected imminently.

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. 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. 

“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.”

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.

Polpharma Biologics is focused on broadening access to biological medicines used to treat some of the world’s most impactful diseases across neurology, immunology, ophthalmology and other therapeutic areas. The company is at the forefront of the next wave in biopharma, leveraging its knowledge, capabilities and footprint to develop its robust pipeline of more than seven biosimilars in early-late-stage development.

About Polpharma Biologics

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas. 

Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.

Disclaimer

This press release is issued from Polpharma Biologics Group B.V. and is intended to provide worldwide information about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group B.V. is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy.

Media contacts

Leah Peyton
Director, Ruder Finn 
Lpeyton@ruderfinn.co.uk
+44 7788 191434

References

*Tysabri^® is a registered trademark of Biogen MA, Inc.

1. Tyruko. Prescribing Information 2023. http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761322

2. MS International Federation. What is MS? October 2021. Available from: https://www.msif.org/about-ms/what-is-ms/ [Accessed July 2023]

3. The Economic Burden of Multiple Sclerosis in the United States Estimate of Direct and Indirect Costs, Bebo B., Neurology May 2022, 98 (18) e1810-e1817; DOI: 10.1212/WNL.0000000000200150