Natalizumab Biosimilar (Polpharma Biologics)

Sandoz expects Tyruko to be a key contributor to the company's growth strategy. The clock is up on Biogen’s extra two years of a biosimilar-free U.S. market for its blockbuster multiple sclerosis (MS) med Tysabri. After waiting in the wings post-FDA approval in 2023, Sandoz’s biosimilar rival Tyruko has officially launched in the U.S.Tyruko is not only the first Tysabri biosimilar, but it’s also the first U.S. biosimilar that can treat MS. The launch marks an “important opportunity to help people with MS navigate this disease in a way that is more cost-effective,” Sandoz’s North America president Keren Haruvi explained in the company’s Nov. 17 press release. Sandoz pinned its name on the drug through a global commercialization agreement with Polpharma Biologics in 2019, which developed Tyruko and handles manufacturing and supply. The biosimilar is also available in 14 European countries and is expected to be a “key contributor to the Sandoz growth strategy,” according to its release, fitting into the company’s ambitions to be “#1 in biosimilars in the US and a leader in the treatment of MS globally.” Sandoz faced several hurdles to secure its approval and launch, starting with a legal challenge (PDF) from Biogen in 2022. A few months after a federal court in Delaware tossed Biogen’s patent infringement case, the FDA blessed Tyruko with an approval in both Tybrasi’s MS and Crohn’s disease indications.Biogen, which brought Tysabri to market in 2004, remained confident that its product would “continue to have a meaningful role in treatment choice for patients and healthcare providers,” a spokesperson told Fierce Pharma in 2024, adding that the company has “been preparing for this scenario.”As it turns out, the Tysabri drugmaker had more time to prepare than anticipated when Sandoz’s launch was held off by a key approval for a John Cunningham virus (JCV) antibody test.JCV antibodies are a risk factor for a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML), which has been linked to the use of Tysabri. Biogen pioneered the concept of testing a patient for JCV to assess PML risk and, in 2012, rolled out STRATIFY with partner Quest Diagnostics, what was the first FDA-approved JCV antibody assay and is used alongside Tysabri.Tyruko, like Tysabri, is available through an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) program given the PML risk associated with the drug. Sandoz was working on its own JCV assay and had initially planned to introduce Tyruko in the first half of 2024, but had to push its launch back to 2025.Earlier this year, a company spokesperson told Fierce Pharma that it “believes we can find a pathway forward with the FDA for approval of the JCV assay, but it is going to take longer than we had originally anticipated.” Labcorp, a Quest Diagnostics rival in the clinical diagnostics space, has since swooped in to help out Sandoz in developing and validating a laboratory-developed test for detecting the presence of anti-JCV antibodies. Labcorp will offer the Tyruko JCV testing program at no cost to eligible patients, as Sandoz will cover the cost of the test, the press release notes.Sandoz counted Tyruko as a contributor to its “notable growth” in European sales over its recent third-quarter financial readout. So far this year, the company has also launched the first interchangeable biosimilars to Amgen’s bone meds Prolia and Xgeva, as well as a copy of Johnson & Johnson’s blockbuster immunology drug Stelara. Biogen, meanwhile, saw slight gains in Tysabri-specific revenue during the third quarter, although 2025’s overall decline in MS sales prompted a greater focus on building up its newer drug launches. Tysabri first achieved blockbuster status in 2009.

AMSTERDAM--(BUSINESS WIRE)--Polpharma Biologics, a biopharmaceutical company group focused on biosimilars development and manufacturing, today confirmed that Sandoz Tyruko® (natalizumab-sztn) is now available to patients in the United States. Tyruko® is the first and only FDA-approved biosimilar of natalizumab for the treatment of relapsing forms of multiple sclerosis (MS), and also for adult patients with moderately to severely active Crohn’s disease1. Tyruko® was developed by Polpharma Biologics and will be commercialized in the U.S. by its collaboration partner Sandoz, under an exclusive global license agreement. The launch marks a significant milestone in expanding access to high-quality, affordable treatment options for patients living with MS and Crohn’s disease in the United States. Emmanuelle Lepine, Chair of the Supervisory Board, Polpharma Biologics, commented: "The U.S. launch of Tyruko® marks a pivotal moment not only for Polpharma Biologics, but for patients across the United States. This milestone reflects our long-term commitment to scientific excellence, global collaboration and expanding access to high-quality biologic therapies. Tyruko® is a testament to the competency and dedication of our teams, and we are proud to see our biosimilar reach patients in need of more affordable treatment options." Polpharma Biologics S.A., a contract development and manufacturing organization (CDMO) operating under the Rezon Bio brand and headquartered in Gdańsk, Poland, is responsible for the commercial supply of the drug substance for Tyruko®. Tyruko® is now available in the U.S. and 14 countries across Europe, representing a major step forward in broadening access to biological medicines for patients worldwide. About Polpharma Biologics Polpharma Biologics is a group of biopharmaceutical companies focused on development and manufacturing of biopharmaceuticals and biosimilars for supply to global markets. Our Swiss based biosimilars focused entity manages the entire value chain: from product selection and investment allocation, through program execution to asset monetization, ensuring fast progress from idea to launch in strong collaboration with our global partners. Our international team of senior experts has proven experience in program leadership, regulatory strategy, CMC integration, device development, clinical oversight, and quality assurance. Working with trusted CDMOs, we deliver end-to-end biosimilars, from cell line to finished product, across a range of major therapeutic areas. Our commercial partners ensure access for patients to these medicines worldwide. Our mission is to accelerate access to biologics. To fulfill that mission, we maintain a robust, expanding pipeline of biosimilars in development. 1 For full prescribing information, please refer to the US FDA Prescribing Information for Tyruko®