FDA Approves Natalizumab Biosimilar, First for Multiple Sclerosis

Sandoz's injection treatment natalizumab-sztn (Tyruko) has been approved by the FDA as the first biosimilar for multiple sclerosis (MS) in the United States.¹

The biosimilar is indicated for the treatment of adults with MS, as well as those with severely active Crohn disease with inadequate response or tolerability to conventional therapy.

“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 statement.² “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.”

Data from the phase 3 Antelope study, a parallel-group, randomized, active-controlled study, found that the biosimilar matched the reference product in efficacy, safety, and immunogenicity for patients with relapsing-remitting MS (RRMS).³

The study included 264 adults with RRMS in 48 centers in 7 different countries. The primary end point was the cumulative number of new active lesions on MRI by 24 weeks. Secondary clinical end points included annualized relapse rate (ARR) and change from baseline Expanded Disability Status Scale (EDSS) score after 24 and 48 weeks.

There was no clinically relevant difference in the mean cumulative number of new active lesions between the 2 groups. The ARR at 24 and 48 weeks was similar for patients on the biosimilar and the reference product. At baseline the EDSS score was similar for both groups and changes were minimal and similar for both groups.

The most common side effects associated with natalizumab products are headache and fatigue.¹ Other common side effects are arthralgia (pain in a joint), urinary tract infection, lower respiratory tract infection, gastroenteritis (stomach flu), vaginitis (infection or inflammation of the vagina), depression, pain in extremity, abdominal discomfort, diarrhea, and rash.

“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,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement.¹

The Prescribing Information for both the natalizumab biosimilar and the reference product (Tysabri) contains a boxed warning to about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability. The presence of anti-JCV antibodies, longer duration of therapy, and prior use of immunosuppressants are all risk factors for the development of PML.

The risk of developing PML while on natalizumab products means they are available only through a restricted drug distribution program, under a risk evaluation and mitigation strategy.

In 2019, Sandoz and Polpharma Biologics entered a global commercialization agreement in which Polpharma Biologics was responsible for development, manufacturing, and supply of the active substance in Tyruko.

References

1. FDA approves first biosimilar to treat multiple sclerosis. News release. FDA. August 24, 2023. Accessed August 25, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-multiple-sclerosis

2. Sandoz receives FDA approval for Tyruko (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis. Novartis. News release. August 25, 2023. https://www.novartis.com/news/media-releases/sandoz-receives-fda-approval-tyruko-natalizumab-sztn-first-and-only-fda-approved-biosimilar-relapsing-forms-multiple-sclerosis

3. Hemmer B, Wiendl H, Roth K, et al. Efficacy and safety of proposed biosimilar natalizumab (PB006) in patients with relapsing-remitting multiple sclerosis: the Antelope phase 3 randomized clinical trial. JAMA Neurol. 2023;80(3):298–307. doi:10.1001/jamaneurol.2022.5007