FDA Approves First Biosimilar of MS Drug Tysabri

The FDA has approved Sandoz’s Tyruko (natalizumab-sztn), the first biosimilar to Biogen’s Tysabri (natalizumab) injection to treat adults with relapsing forms of multiple sclerosis (MS). Developed by Polpharma Biologics, 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.

Multiple sclerosis is an autoimmune disease of the central nervous system. It is among the most common causes neurological disability in young adults and occurs more frequently in women than men. Most people with MS experience periods of new symptoms or relapses that improve partially or completely, followed by periods of disease remission.

Tyruko is expected to be available as soon as possible. A Sandoz spokesperson said launch timing will be dependent on other factors, including FDA approval of its JCV assay (a test to detect the level of antibodies for a virus that can be carried to the brain), as well as having HCPCS code in place. The spokesperson would not comment on the price at this point but said the “aim with every launch of a biosimilar is to increase patients’ access to critical biologic medicines and introduce competition that can drive down costs and fuel innovation.”

The prescribing information for both Tyruko and Tysabri contains a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability. Because of this risk, both products are available under a risk evaluation and mitigation strategy (REMS). As part of the REMS requirements, prescribers must evaluate patients three and six months after the first infusion, every six months.

Bari Talente

“Access to affordable, high-quality healthcare is essential for people with multiple sclerosis to live their best lives,” Bari Talente, the National MS Society’s executive vice president for advocacy and healthcare access, said in a press release. “The approval of Tyruko, the first FDA-approved biosimilar disease-modifying treatment for people with relapsing forms of MS, is a milestone. Biosimilars are an important treatment option because they have no clinically meaningful differences from their reference medicines. Prescribing them can increase accessibility to affordable medications, improve adherence and help contain healthcare costs.”

Sandoz entered into a global commercialization agreement for Tyruko with Polpharma Biologics in 2019. Polpharma Biologics will maintain responsibility for development, manufacturing and supply of the active substance in Tyruko. Sandoz has the rights to commercialize and distribute it in all markets.

The approval of Tyruko was based on data from the phase 3 Antelope study conducted by Polpharma Biologics. The Antelope study met its primary endpoint, showing comparable efficacy for cumulative combined unique active (CUA) lesions. Together with the phase I (PK/PD) study, which also met its primary endpoint, the studies demonstrated that the Tyruko biosimilar matched the efficacy and safety of the reference medicine, the company announced in July 2022.